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JUMBO JOBS - A JOB SCAMMER - BE CAREFUL

As you all know, every day a new job scam come in to picture and lots of people caught up with these job scams and loss so much money due to unawareness whether the offerings was of a scam or really good opportunity

As an example, in January 2019 a big job scam of www.wisdomjobs.com was blasted out that has cheated more than one lakh people (Approximately 70 cores) and the wisdom management was got arrested.

Now, similarly Jumbo jobs is doing the same again and cheated and trying to cheat so many people just by offering fake jobs and collecting money from the victims.

Refer following as few examples.

I personally had experience with this Jumbo jobs. One day ‘Geetha’ from Jumbo jobs called me and told that they looking for good candidates for position that exactly matches my current job profile. 

Later i verified in the web and found it is scam and same was discussed during call from jumbo jobs and immediately they said its ok... its ok and disconnected the call.

Refer below communication . Please be careful

Dear Mr. Kiranreddy Munnangi,
Greetings from Jumbo-Jobs,
Jumbo-Jobs based in India is a global leader in successfully connecting job opportunities and people. Jumbo-Jobs main Purpose is to improve the efficiency of recruitment. The recruitment process has four stages such as sourcing, engaging, selecting, and hiring. We’ll look at the market for recruitment tools from the point of view of recruitment stages We use the world's most advanced technology to help people in finding better job opportunities via digital, social and mobile solutions including Info@jumbo-jobs.com

Our primary business focuses Recruitment & Job Enhancement in 7 countries (Gulf, India, Canada, Australia, USA, Singapore, Malaysia).

Jumbo jobs is the India’s latest online search engine with new technologies which provides relevant profiles to employers and relevant jobs to job seekers across industry verticals, experience levels and geographies. Our international reach helps in dealing global employment services at domestic as well as at international level. We serve our clients keeping all their requirements and parameters into consideration and help them in getting relevant yet best responses in required time.

There is a position available for (Sr.Manager - QA/ Senior Level Position) in one of the leading (Pharma / Biotech / Clinical Research) industry based in (United Arab Emirates, Qatar) which suits your qualifications and experience as demonstrated by your resume on one of the job boards.

We have short-listed your resume to the above mentioned requirement directly with our client. If your are open for a change, we will forward your resume to prospective clients in above mentioned location.

Below are the details of Salary & Benefits:

Date Posted
15th  Oct 2019
Position Type
Permanent
Designation
Sr.Manager - QA
Nationality  
Any English Speaking
Industry
Pharma / Biotech / Clinical Research
Years of Experience
(13) Years+
Functional Area
Quality / Testing / QA / QC / Inspector
Availability To Join
90 days or less 
Number of Vacancies
2
Salary Range
USD  (5500 to 6500) Basic Negotiable + Benefits.
Work Location
United Arab Emirates, Qatar


Additional Benefits
Housing Allowaces
Subsidized Healthcare Package For You And Your Family
Medical & Life Insurance (As per Country’s Law)
Transport Benefits
Education Allowance For Children
Excellent Bonus Schemes
Paid Annual Leave (30 - 45 Days)
Round Trip – Annual Leave Family Air Tickets Per Year To Your Point Of Hire

Organization Type

MNC































T& C:-

1. The total cost of the services and the entire recruitment process including the registration charges is USD 600 out of which you have to pay 50% upfront which is USD 300 for the registration process, and remaining USD 300 you have to pay from your 1st month of salary after joining the client.
2. If Jumbo-Jobs fails in providing the relevant job opportunities in 90 days, the whole amount which you have paid for the services will be refunded.
3. The Client details will be disclosed only after registration process.


Awaiting for your immediate Response.


Thanks & Regards,
Geetha HR Manager
Contact number :+917093712674

Jumbo-Jobs - Agreement Form

SERVICE TERMS &CONDITIONS
Agreement (“Agreement”) is made by and between Jumbo-Jobs (“Recruitment Consultant”) and Mr. Kiranreddy Munnangi with its affiliates and subsidiaries.
First Party: Jumbo-Jobs
And
Second Party: Mr. Kiranreddy Munnangi
IT IS HEREBY AGREED AS FOLLOWS:

This Agreement shall commence on 16thOct 2019 (the “Start Date”) and Jumbo-Jobs shall provide the services detailed below for a period of 90 days from the Start Date i.e. 16-10-2019 till 15-01-2019.

Jumbo-Jobs will provide the candidate with the name of the client they have already approached and will also provide details of any other clients who are interested in the resume for the duration of 90 Days.

Terms and Conditions
Jumbo-Jobs select and apply on behalf of candidates for either permanent/temporary employment on the following terms and conditions:
It is client who acknowledges and agrees that they are solely responsible for the recruitment decision they make. It is important that the client is entirely satisfied with a candidate before engagement.
Jumbo-Jobs will spot current job openings from various sources and we share job opportunities with the candidate with his/her accord. The details of the job roles and responsibilities along with a brief depiction about the prospective companies will be shared.

CONFIDENTIALITY
Any information supplied to a client by Jumbo-Jobs regarding a candidate is done so on a strictly confidential basis to enable the client to assess a candidate’s suitability for the position and except where authorized or required by law shall not be disclosed to any third party without the express written consent of the candidate.
Jumbo-Jobs endeavors to obtain accurate details on all candidates including their qualifications and experience. Jumbo-Jobs is however reliant on the integrity of information supplied to it by potential candidates placed by Jumbo-Jobs.• The total cost of the services and the entire recruitment process including the registration charges is USD 600 out of which you pay only USD 300 upfront, remaining USD 300 will be charged after you complete your probation period in the company.
The client shall be solely responsible for any failure in the interview. No liability is accepted by Jumbo-Jobs for any errors, expenses, loss and damage.

Jumbo-Jobs will ensures further and will arrange an alternate opportunity without any additional charges.• If Jumbo-Jobs fail in providing job Opportunities within 90 days, total amount which the Job Seeker has paid in advance for the services will be refunded.
We see our company as a bridge between jobseekers and employers adding value, productivity and a happy environment and career for all involved. We also help promote your profile to a wide range of people who know the value of your profile.

Jumbo-Jobs Date: 16th Oct 2019

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PROCESS VALIDATION

Validation:
Validation is the action of proving or declaring something (Procedure, process & equipment etc) that actually capable to deliver expected results and is officially valid.

Process Validation:
Process validation is the action of proving or declaring that the established process is capable to deliver expected results and is officially valid.

Objective of process Validation
To generate a documented evidence, from the evaluation of data from process design stage through commercial production, that provides a high degree of assurance that a specific process will consistently results in a product that meets predetermined specification and quality characteristics.




Process validation should not be viewed as a one-off event. Process validation incorporates a life cycle approach linking product and process development, validation of the commercial manufacturing process and maintenance of the process in a state of control during routine commercial production.

The objective of process validation consists of following major steps. 

  • The process design is evaluated to show that it is reproducible,
  • The commercial manufacturing process is defined and controlled,
  • Ongoing assurance is gained to show that the process remains in a state of control.

Types of Process Validation:

Process validation mainly divided in to following four types.

a) Prospective Validation (Premarket Validation)
b) Concurrent Validation
c) Retrospective Validation
d) Re-validation


A) Prospective Validation (Premarket Validation) 

This approach to validation is normally undertaken during development stage by means of a risk analysis of the process, generally whenever the process for a new formula (or within a new facility) must be validated before routine pharmaceutical production commences. 

In fact, validation of a process by this approach often leads to transfer of the manufacturing process from the development function to production.

Prospective validation should be completed before commercial distribution.

B) Concurrent Validation: 

Concurrent validation is carried out during normal production. 

This method is effective only if the development stage has resulted in a proper understanding of the fundamentals of the process.

The first three production-scale batches must be monitored as comprehensively as possible. The nature and specifications of subsequent in-process and final tests are based on the evaluation of the results of such monitoring.

This validation generally used for batches produced infrequently and/or batches are produced by a validated process that has been modified.

Prior to the completion of concurrent validation, batches can be released.


C) Retrospective Validation: (Regulatory not considering this as on date) 

Retrospective validation is used for facilities, processes, and process controls in operation use that have not undergone a formally documented validation process.

Retrospective validation is obviously not a quality assurance measure in itself, and should never be applied to new processes or products. It may be considered in special circumstances only, e.g. when validation requirements are first introduced in a company. 

Retrospective validation may then be useful in establishing the priorities for the validation programme. If the results of a retrospective validation are positive, this indicates that the process is not in need of immediate attention and may be validated in accordance with the normal schedule.

Batches selected for retrospective validation should be representative of all batches made during the review period, including any batches that failed to meet specifications, and should be sufficient in number to demonstrate process consistency. Retained samples can be tested to obtain data to retrospectively validate the process.

D) Re-Validation: 

Re-validation means repeating the original validation effort or any part of it, and includes investigative review of existing performance data.

Re validation is needed to ensure that changes in the process and/or in the process environment, whether intentional or unintentional, do not adversely affect process characteristics and product quality.

Possible reasons for re-validation:
a) Periodic re-validation
b) Re-validation after change in the starting material
c) Re-validation after change in the packing material
d) Re-validation after change in the process
e) Re-validation after change in the equipment or measuring instrument
f) Re-validation after change in the production area or supporting system.
g) Re-validation after significant change in the batch size

Traditional Approach of Process Validation:
Traditionally process validation was focused on testing, instrument qualification, and process robustness and repeatability.

Traditional approach includes following four elements

Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Process Validation (PV)

In this approach the manufacturer performs a minimum of 3 commercial batches for validation and if successful, the validation effort is considered complete, and manufacturer could then routinely use the process to produce the product, without further process validation and there was no requirement to perform any further ongoing life cycle validation efforts.


Modern Approach of Process Validation (Life Cycle Approach):

Against to traditional approach, the current enhanced process validation approach consists three phase continuous process with ongoing effort for the entire life cycle of the product called as life cycle approach.

Phase I. Process design

Phase II. Qualification and process verification

Phase IIA. Qualification

Phase IIB. Continuous process performance verification

Phase III. Continued process verification



Phase I. Process design:

The goal of this stage is to design a process suitable for routine commercial manufacturing process that can consistently deliver a product that meets its quality attributes. 
Process design should normally cover design of experiments, product & process development, and the manufacture of products for use in clinical trials, pilot-scale batches and technology transfer. 
Process design should cover aspects for the selection of materials, expected production variation, selection of production technology/process and qualification of the unitary processes that form the manufacturing process as a whole, selection of in-process controls, tests, inspection and its suitability for the control strategy. 


Product & Process development: 
The aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. 
It is important to recognize that quality cannot be tested into products; i.e., quality should be built in by design. 
At the completion of this stage technology transfer package containing information sufficient to plan and manufacture scale up & exhibit batches shall be made available. 
A development report and/or a technology transfer document, formally reviewed and approved by research and development personnel, and formally accepted by manufacturing, engineering and quality personnel, should be prepared. 
Such a document may include information, desired clinical performance, bills of materials, approved suppliers, finished product specifications and test methods, in-process testing specifications, equipment recommendations, master batch production records, master batch packaging records, stability reports, critical quality attributes, critical process parameters, batch comparisons, data on formulation batches, stability batches, clinical/ bio batches and scale-up batches. These documents should be readily available to the manufacturing site. 


Scale up activities: 
The aim of scale up activities is to assess the impact of scaling up of manufacturing process on the performance of manufacturing process and product quality. 
At the completion of this stage, control strategy of for manufacturing process for validation batches should be made available. 
A scale up report, formally reviewed and approved by research and development personnel, manufacturing and quality personnel, should be prepared. 
Such a document may include information related to Product, Manufacturing process, process evaluation and recommended control strategy with conclusion as a minimum criteria. 
— As part of the process validation life cycle some process validation studies may be conducted on pilot-scale batches (corresponding to at least 10% or 100 000 units, whichever is the greater) of the production scale. Where the batch size is smaller and/or where the process is tailored to the geometry and capacity of specific equipment, it may be necessary to provide production-scale validation data.
— The number of batches included in the process design stage of validation should be appropriate and sufficient to include (but not be limited to) the expected variations in starting materials, and confirm the suitability of the equipment and manufacturing technology
— Manufacturers should define the stage at which the product is considered to be validated and the basis on which that decision was made. It should include a justification for the number of batches used based on the complexity and expected variability of the process.


Phase II. Qualification and process verification:






This phase consist of following sub-phases.






Phase IIa: Qualification of personnel, premises, utilities, and equipment’s where commercial scale batches will be manufactured.
Phase IIb: Continuous process performance verification.






Phase IIa: 
Personnel Premises, utilities, support systems and equipment should be appropriately qualified before process performance verification (as part of validation) is started. 
In a traditional approach, stages of qualification may include design, installation, operational and performance qualification. 
In some cases process validation may be conducted concurrently with performance qualification. 


Phase IIb: 
After completion of qualification, commercial batches should be subjected to continuous process performance verification as part of process validation. It should confirm that scale up in batch size do not adversely affect the characteristics of a product. 
Demonstrates that a process that operates within the predefined specified parameters consistently produces a product which meets all its critical quality attributes (CQAs) and control strategy requirements 
The process should be verified on commercial-scale batches prior to marketing of the product. 
Extensive in-line or at-line controls should be used to monitor process performance and product quality in a timely manner. In most cases, PPQ will have a higher level of sampling, additional testing, and greater scrutiny of process performance than would be typical of routine commercial production. 
Manufacturers should describe the appropriateness and feasibility of the CPV strategy including the process parameters and material attributes that will be monitored as well as the analytical methods that will be employed. 
It is expected that additional monitoring for the first commercial batches should be done where continuous process verification is implemented. 


Phase III. Continued process verification: 
Manufacturers should monitor product quality of commercial batches after completion of Phase I and Phase II of process validation. This will provide evidence that a state of control is maintained throughout the product life-cycle 
Periods of enhanced sampling and monitoring may help to increase process understanding as part of continuous improvement. 
Process trends such as the quality of incoming materials or components, in-process and finished product results and non-conformances should be collected and assessed in order to verify the validity of the original process validation or to identify required changes to the control strategy. 
The extent and frequency of ongoing process validation should be reviewed periodically and modified if appropriate throughout the product life-cycle. 

Traditionally process validation was focused on testing, instrument qualification, and process robustness and repeatability.
Traditional approach includes following four elements
Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Process Validation (PV)

In this approach the manufacturer performs a minimum of 3 commercial batches for validation and if successful, the validation effort is considered complete, and manufacturer could then routinely use the process to produce the product, without further process validation and there was no requirement to perform any further ongoing life cycle validation efforts.

Modern Approach of Process Validation (Life Cycle Approach):
Against to traditional approach, the current enhanced process validation approach consists three phase continuous process with ongoing effort for the entire life cycle of the product called as life cycle approach.

Phase I. Process design

Phase II. Qualification and process verification

Phase IIA. Qualification

Phase IIB. Continuous process performance verification

Phase III. Continued process verification


Phase I. Process design:

The goal of this stage is to design a process suitable for routine commercial manufacturing process that can consistently deliver a product that meets its quality attributes.
Process design should normally cover design of experiments, product & process development, and the manufacture of products for use in clinical trials, pilot-scale batches and technology transfer.
Process design should cover aspects for the selection of materials, expected production variation, selection of production technology/process and qualification of the unitary processes that form the manufacturing process as a whole, selection of in-process controls, tests, inspection and its suitability for the control strategy.


Product & Process development:
The aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product.
It is important to recognize that quality cannot be tested into products; i.e., quality should be built in by design.
At the completion of this stage technology transfer package containing information sufficient to plan and manufacture scale up & exhibit batches shall be made available.
A development report and/or a technology transfer document, formally reviewed and approved by research and development personnel, and formally accepted by manufacturing, engineering and quality personnel, should be prepared.
Such a document may include information, desired clinical performance, bills of materials, approved suppliers, finished product specifications and test methods, in-process testing specifications, equipment recommendations, master batch production records, master batch packaging records, stability reports, critical quality attributes, critical process parameters, batch comparisons, data on formulation batches, stability batches, clinical/ bio batches and scale-up batches. These documents should be readily available to the manufacturing site.


Scale up activities:
The aim of scale up activities is to assess the impact of scaling up of manufacturing process on the performance of manufacturing process and product quality.
At the completion of this stage, control strategy of for manufacturing process for validation batches should be made available.
A scale up report, formally reviewed and approved by research and development personnel, manufacturing and quality personnel, should be prepared.
Such a document may include information related to Product, Manufacturing process, process evaluation and recommended control strategy with conclusion as a minimum criteria.
 — As part of the process validation life cycle some process validation studies may be conducted on pilot-scale batches (corresponding to at least 10% or 100 000 units, whichever is the greater) of the production scale. Where the batch size is smaller and/or where the process is tailored to the geometry and capacity of specific equipment, it may be necessary to provide production-scale validation data. — The number of batches included in the process design stage of validation should be appropriate and sufficient to include (but not be limited to) the expected variations in starting materials, and confirm the suitability of the equipment and manufacturing technology — Manufacturers should define the stage at which the product is considered to be validated and the basis on which that decision was made. It should include a justification for the number of batches used based on the complexity and expected variability of the process.

Phase II. Qualification and process verification:





This phase consist of following sub-phases.





Phase IIa: Qualification of personnel, premises, utilities, and equipment’s where commercial scale batches will be manufactured. Phase IIb: Continuous process performance verification.





Phase IIa:
Personnel Premises, utilities, support systems and equipment should be appropriately qualified before process performance verification (as part of validation) is started.
In a traditional approach, stages of qualification may include design, installation, operational and performance qualification.
In some cases process validation may be conducted concurrently with performance qualification.


Phase IIb:
After completion of qualification, commercial batches should be subjected to continuous process performance verification as part of process validation. It should confirm that scale up in batch size do not adversely affect the characteristics of a product.
Demonstrates that a process that operates within the predefined specified parameters consistently produces a product which meets all its critical quality attributes (CQAs) and control strategy requirements
The process should be verified on commercial-scale batches prior to marketing of the product.
Extensive in-line or at-line controls should be used to monitor process performance and product quality in a timely manner. In most cases, PPQ will have a higher level of sampling, additional testing, and greater scrutiny of process performance than would be typical of routine commercial production.
Manufacturers should describe the appropriateness and feasibility of the CPV strategy including the process parameters and material attributes that will be monitored as well as the analytical methods that will be employed.
It is expected that additional monitoring for the first commercial batches should be done where continuous process verification is implemented.


Phase III. Continued process verification:
Manufacturers should monitor product quality of commercial batches after completion of Phase I and Phase II of process validation. This will provide evidence that a state of control is maintained throughout the product life-cycle
Periods of enhanced sampling and monitoring may help to increase process understanding as part of continuous improvement.
Process trends such as the quality of incoming materials or components, in-process and finished product results and non-conformances should be collected and assessed in order to verify the validity of the original process validation or to identify required changes to the control strategy.
The extent and frequency of ongoing process validation should be reviewed periodically and modified if appropriate throughout the product life-cycle.

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AUDIT TRAIL AND ITS IMPORTANCE




What is Audit Trail?

Audit trail means a secure recording of life cycle details such as creation, addition, alteration or deletion of information in record either paper or electronic, without obscuring or overwriting the original record.

An audit trail facilitates the reconstruction of history of such events relating to the record regardless its medium, including who, what, when and why of the action.

The audit trail should include the following parameters:

- Who made the change?- What was changed, incl. old and new values- When the change was made, incl. date and time- Why the change was made (reason)- Name of any person authorizing the change.

For example,
In a paper record, an audit trail of a change would be documented via a single-line cross-out that allows the original entry to remain legible and documents the initials of the person making the change, the date of the change and the reason for the change, as required to substantiate and justify the change.

In electronic records, secure, computer-generated, time stamped audit trails should allow for reconstruction of the course of events relating to the creation, modification and deletion of electronic data. Computer generated audit trails should retain the original entry and document the user identification, the time/date stamp of the action, as well as the reason for the change, as required to substantiate and justify the action.

Computer-generated audit trails may include discrete event logs, history files, database queries or reports or other mechanisms that display events related to the computerized system, specific electronic records or specific data contained within the record.

All processes to be designed so that data required to be created and maintained cannot be modified without a record of the modification. i.e Audit trail.

For example, chromatographic data should be saved to durable media upon completion of each step or injection (e.g., peak integration or processing steps; finished, incomplete, or aborted injections) instead of at the end of an injection set, and changes to the chromatographic data or injection sequence should be documented in an audit trail. Aborted or incomplete injections should be captured in audit trails and should be investigated and justified.

Where Audit trail required?

Audit trail information required throughout the Data life cycle as follows.· Data generation and capture;· Data transmission;· Data processing;· Data review;· Data reporting, including handling of invalid and atypical data;· Data retention and retrieval; back-up & Archival· Data disposal.
Audit trails (identified by risk assessment as required) should be switched on for each electronic system. Users should not be able to amend or switch off the audit trail. Where a system administrator amends, or switches off the audit trail a record of that action should be retained.

Similarly appropriate system should develop for manual systems to track attributable information for each activity.

I.e recording of attributable information in the respective documents/records like who, when, what and why of the activity.

An example of Audit trail environment:

Let’s assume the operator enters the batch number (manually, via keyboard) and confirms his data entry (Button OK). His first entry is now saved as electronic data, comparable when written on paper of the batch production record. It might be that he or his colleague finds out that the wrong number (transposed digits) was entered. The wrong entry can be corrected in real-time directly by the operator on the system (if we want that) by having detailed view on data audit trail as follows.
  1. Operator enters batch number into the system
  2. Operator presses the OK button or signed electronically with his user name & password – data is saved (version 1)
  3. Operator realizes a wrong batch number entry and need to change the initial batch number entry
  4. Operator reopens the data object and corrects the batch number
  5. Operator presses the OK button or and signed electronically with his user name & password to confirm batch number change – batch number is saved (version 2)
  6. Second operator (or shift coordinator or QA) verifies the change of batch number and signed electronically with his user name and password – double signature
How to review in Audit trails?

Routine data review should include a documented audit trail review where this is determined by a risk assessment.
  • Determining the risk-based approach to review electronic data and required audit trails based upon process understanding and knowledge of potential impact on products and patients;
  • Writing SOPs defining review of original electronic records and including meaningful metadata such as audit trails and review of any associated printouts or PDF records;
  • Documenting the system architecture and data flow, including the flow of electronic data and all associated metadata, from the point of creation through archival and retrieval;
  • Ensuring that the relationships between data and metadata are maintained intact throughout the data life cycle.
When designing a GXP system for review of audit trails, Audit trails may be reviewed as a list of relevant data, or by an ‘exception reporting' process.
An exception report is a document that states those instances in which actual performance deviated significantly from expectations, usually in a negative direction. The intent of the report is to focus data reviewer attention on just those areas requiring immediate action
For example,
An exception report can be prepared for a chromatographic analysis with following parameters that can reflect all possible abnormalities.

Channel Audit trail summary report:

Which contains Sample set Name, Sample set Id, Instrument method name, sample Name, system name, Channel Id, Run Time (Minutes), Data end time (Minutes), No. of result stored as minimum requirement.

Abnormalities that can be identified but not limited to:
  1. Duplicate injections in sample set or sequence
  2. Aborted or interrupted injection in the sequence
  3. Unprocessed channels
  4. Rut time differences in between runs
  5. Delays in between injections
  6. Instrument method changes in between sequence
Result Audit trail summary report:

Which contains Sample set Name, sample set ID, Instrument method name, Sample Name, system name, Channel ID, Processing method, Faults, Results, No. of result stored, Date Acquired, Acquired By, Date Processed, Processed by, Result Id and Manual as minimum requirement.

Following abnormalities that can be identified:
  1. Reprocessed channels
  2. Faulty injections
  3. Processed with different processing methods
  4. Manual integrations
  5. Delay in processing
Key personnel, including managers, supervisors and quality unit personnel, should be trained in measures to prevent and detect data issues. This may require specific training in evaluating the configuration settings and reviewing electronic data and metadata, such as audit trails, for individual computerized systems used in the generation, processing and reporting of data.

For example, the quality unit should learn how to evaluate configuration settings that may intentionally or unintentionally allow data to be overwritten or obscured through the use of hidden fields or data annotation tools. Supervisors responsible for reviewing electronic data should learn which audit trails in the system track significant data changes and how these might be most efficiently accessed as part of their review.

Companies should implement procedures that outline their policy and processes for the review of audit trails in accordance with risk management principles. Critical audit trails related to each operation should be independently reviewed with all other records related to the operation and prior to the review of the completion of the operation, e.g. prior to batch release, so as to ensure that critical data and changes to it are acceptable. This review should be performed by the originating department, and where necessary verified by the quality unit, e.g. during self-inspection or investigative activities.

A procedure should describe the actions to be taken if data review identifies an error or omission. This procedure should enable data corrections or clarifications to provide visibility of the original record, and traceability of the correction, using ALCOA principles


What to review in Audit trails?

The relevance of data retained in audit trails should be considered by the organization to permit robust data review/verification. It is not necessary for audit trail review to include every system activity (e.g. user log on/off, keystrokes etc.).

Should not be expect to implement forensic approach during routine checking.

The activities that required audit trail review should be decided based risk assessment and as follows but not limited.

From System audit trail: (but not limited)

a) Unauthorized System policy/Configuration alterations
b) Unauthorized user creation, modification & deletion.
c) Unauthorized user Type/ user level creation, modification & deletion
d) Unauthorized user Group creation, modification & deletion
e) Unauthorized project/ folder creations, modification & deletion
f) Unauthorized data paths

From Data audit trail: (but not limited)

a) Activity/ process breakupsb) Additional data sheet issuancec) Instrument or equipment alarmsd) Critical process parameters deviationse) Process stat and stops against master instructionsf) Unauthorized issuanceg) Unauthorized releaseh) Unauthorized printingsi) Aborted single injection/Sample setj) Unprocessed channelsk) Interrupted injections without proper documentationl) Multiple processing data/ Number of results stored.m) Faulted chromatogramsn) Manually integrated data/ Created manual resultso) Unauthorized method modifications, Method revisions and its changes.

Who should review audit trails?

Audit trail review is similar to assessing cross-outs on paper when reviewing data. Personnel responsible for record review under CGMP should review the audit trails that capture changes to data associated with the record as they review the rest of the record

For example, all production and control records, which includes audit trails, must be reviewed and approved by the quality unit.

The regulations provide flexibility to have some activities reviewed by a person directly supervising or checking information based on criticality of activity.

Reviewers should have sufficient knowledge and system access to review relevant audit trails, raw data and metadata

How often should audit trails be reviewed?

The basic approach for the audit trail review frequency is to review the audit trail after each significant step in manufacture, processing, packing, or holding, and requires data/audit trail review before batch release.

Audit trail review frequency should be based on knowledge of process and risk assessment includes evaluation of data criticality, control mechanism and impact on product quality.

As an industry practice, the audit trail of activities that directly impact the product quality or integrity of analytical results should reviewed on daily basis i.e immediate after completion of action. The audit trails of non-critical activities should be reviewed on predefined (Monthly) frequency. But all decisions should be based on risk assessment only.


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