Академический Документы
Профессиональный Документы
Культура Документы
Sign By
Date
Quality Assurance Department
Audit Training Manual
Title: AUDIT TRAINING MANUAL. Revision No. 00
Doc. No: Effective Date: Supersede Date: Review Date:
QA/ATM/001 07/06/2010 07/06/2012
OBJECTIVE
The objective of this “Audit Training Manual” is to serve as a reference document for
performing Internal Quality Audits at Benzochem Industries Pvt. Limited.
SCOPE
This audit training manual is to be used for auditing the following systems:
2. Determine if there are any outstanding corrective actions from previous internal
audits or regulatory inspections involving documentations.
b. Verify that data added to process documents is correct and current with
the process.
8. Verify that documents are identified with appropriate control and access
statements.
9. Verify that the site has a method for assuring that only current versions of
documents are used.
10. Verify that documents are reviewed or revised either on a scheduled frequency
as needed, whichever is the shorter time interval.
Quality Assurance Department
Audit Training Manual
Title: AUDIT TRAINING MANUAL. Revision No. 00
Doc. No: Effective Date: Supersede Date: Review Date:
QA/ATM/001 07/06/2010 07/06/2012
11. Verify that there are SOPs for managing the documentation system. This
should include review and approval process for documents including those which
require change control management.
12. Verify that personnel understand the differences when signing in different
capacities.
16. Verify that one of the Quality Unit’s responsibilities is to approve all
appropriate quality related documents.
17. Ensure that personnel have received adequate training on new or revised
versions of documents.
19. Verify that the training program incorporates requirements for temporary
employees and consultants.
21. Verify that superseded documents are removed when a new procedure is
issued.
22. Verify that revisions to documents are only made by authorized personnel.
23. Verify that documents are reviewed and/or revised according to an established
frequency.
24. Ensure that documents are retained according to a site retention schedule.
27. Verify that manufacturing records are held for a minimum of one past
expiration dating.
Quality Assurance Department
Audit Training Manual
Title: AUDIT TRAINING MANUAL. Revision No. 00
Doc. No: Effective Date: Supersede Date: Review Date:
QA/ATM/001 07/06/2010 07/06/2012
a. Verify that components, drug product containers, and closures are received,
identified, stored, handled, sampled, tested, and approved or rejected
according to the site’s SOP.
2. Ensure that there are written procedures which describe how each of the previous
operations are performed.
iii. Carrier
5. Verify that the site has an approved vendor list and that materials come from
approved vendors.
Quality Assurance Department
Audit Training Manual
Title: AUDIT TRAINING MANUAL. Revision No. 00
Doc. No: Effective Date: Supersede Date: Review Date:
QA/ATM/001 07/06/2010 07/06/2012
7. Verify that components are identified after receipt and quarantined until released.
8. Ensure that components are identified so the status (quarantine, approved, or rejected)
is known.
9. Review the criteria for removing components from quarantine and challenge the
system.
10. Determine what records are maintained in the storage area to document the movement
of components to other areas.
11. Ensure the site has a system and procedure to manage rejected and returned
components and packaging materials.
12. Review the sampling and testing procedures for components, and the process by
which approved materials are released for use.
13. Ensure that the firm’s inventory system is valid and accurate for drug components,
and packaging material including labels.
c. Ensure that inventory system can provide an accurate and complete listing of
rejected materials on site and verify.
14. Ensure that the site has shown that the containers and closures are compatible with the
product, will provide adequate protection for the drug against deterioration or
contamination, are not additive or absorptive, and are suitable for use
a. Verify that specifications for containers, closures, and desiccant, etc. are
appropriate.
b. Verify that cleaning procedures are adequate and containers are stored
properly.
Quality Assurance Department
Audit Training Manual
Title: AUDIT TRAINING MANUAL. Revision No. 00
Doc. No: Effective Date: Supersede Date: Review Date:
QA/ATM/001 07/06/2010 07/06/2012
15. Ensure that training has taken place for all personnel who handle materials.
16. Ensure that any changes to the material handling system follow the site’s/company
change control procedure.
17. Ensure that there is uninterrupted traceability from finished product to source of
materials.
18. Ensure that at least one specific identity test is conducted on each lot of each
component.
19. Ensure that each lot of components and packaging material is identified.
20. Ensure that representative samples are collected, tested or examined using appropriate
means.
22. Ensure that the site performs a documented investigation into any unexpected
discrepancy.
Quality Assurance Department
Audit Training Manual
Title: AUDIT TRAINING MANUAL. Revision No. 00
Doc. No: Effective Date: Supersede Date: Review Date:
QA/ATM/001 07/06/2010 07/06/2012
1. Find out which products are tested and the test methods used.
2. Choose at least one product with specifications and test methods as detailed.
3. Request a list of laboratory SOPs.
4. Request a list of laboratory equipment.
5. Request a list of laboratory deviations/OOS investigations from the previous 12
months.
6. Review previous audits and regulatory audits to determine if there are pending
actions.
viii. Ensure pharmacopoeial methods are verified for use in the laboratory.
ix. Ensure that methods used are validated for their intended purpose.
x. Ensure that there are validation reports on file for the test methods.
3. Reference standards
i. Ensure that assigned purity is stated, where required and Certificate of
Analysis for the standard is available in the laboratory.
ii. Ensure that reference standards are stored under correct storage
conditions.
iii. Ensure that storage conditions are monitored.
iv. Ensure that reference standards are within expiration date.
v. Ensure that standard preparations are labelled and stored correctly.
vi. Ensure that storage time for standard preparations is valid.
vii. Ensure that there are SOPs available for direction on handling and
storing reference standards.
viii. Review reference standard logbooks to confirm that the standards are
being held under proper conditions.
ix. Ensure there is a system in place for the traceability of reference
standards.
4. Reagents
i. Ensure that the grade of reagent is the same as specified.
ii. Ensure that the reagent is properly labelled, stored, and has an assigned
expiration/or re-assay date.
iii. Ensure that the water used to prepare the reagent is of the purity
required in the site SOP for preparation of the reagent.
iv. Ensure that the lot number is recorded when a reagent is prepared.
v. Review reagent preparation logbooks.
5. Volumetric Solutions
i. Ensure there is an approved preparation procedure in place.
ii. Ensure that the data is recorded and easily accessible.
iii. Determine what the expiration and re-standardization dates are.
iv. Determine if they agree with the Pharmacopoeia.
6. Glassware
i. Ensure that Type A glassware is used for quantitative work.
ii. Ensure that there are standard procedures in place for cleaning
laboratory equipment and components (i.e. pipettes, volumetric flasks,
etc.)
iii. Ensure there are storage instructions for clean glassware in place.
7. Data and reports
i. Ensure that data is checked by a second person.
ii. Ensure that there is an approved SOP on the topic of second person
review.
Quality Assurance Department
Audit Training Manual
Title: AUDIT TRAINING MANUAL. Revision No. 00
Doc. No: Effective Date: Supersede Date: Review Date:
QA/ATM/001 07/06/2010 07/06/2012
iii. Ensure that data is secure with only authorized personnel able to access
it.
iv. Ensure that raw data is recorded in a notebook or on controlled sheets
of paper, not on loose paper.
v. Ensure that data is reported correctly according to approved procedure,
i.e. each data point is recorded, as specified in the SOP, versus an
average taken.
vi. Ensure that any data reported includes its units of measurement.
vii. Review data for the chosen product and ensure that correct
specifications and methods are used
viii. Ensure that relevant system suitability tests are run as appropriate.
ix. Ensure that reagents, solutions, standards and instruments used are
traceable.
x. Ensure that analytical data is being trended and the collected data
evaluated.
8. Analyst’s Notebook
i. Ensure that all written raw data is recorded in notebooks or controlled
worksheets.
ii. Ensure that the number and version/date of the method is recorded.
iii. Ensure that the exact method as described in the SOP has been
followed.
iv. If there is deviation from the procedure, ensure that the supervisor or
authorized person according to SOP has approved the deviation.
v. Ensure equipment is identified including serial numbers of columns.
vi. If applicable, ensure that standard and sample weights are recorded
according to established procedure.
vii. If applicable, ensure that standard concentration calculations are
documented.
viii. Ensure that notebooks are controlled.
ix. Ensure that notebooks are reviewed by a second person for accuracy
and completeness.
x. Ensure that the analyst signs and dates each day data are recorded.
xi. Ensure that all entries that are crossed out are initialled and dated
according to an approved SOP.
xii. Ensure systems for archiving of electronic data or notebooks are
present
9. Out-of-Specification
i. Ensure that the site has an SOP in place.
ii. Ensure that the site is following the SOP through review of OOS
investigations.
Quality Assurance Department
Audit Training Manual
Title: AUDIT TRAINING MANUAL. Revision No. 00
Doc. No: Effective Date: Supersede Date: Review Date:
QA/ATM/001 07/06/2010 07/06/2012
iii. Ensure that once an OOS is discovered, the rationale for the
subsequent steps is based on sound scientific reasoning.
10. Change Control Program
i. Ensure that methods, equipment, software and instrumentation are part
of the change control program.
ii. Ensure that appropriate approvals and levels of approval are in place.
iii. Ensure that testing after the modification or change is performed.
iv. Ensure the results are within the acceptance criteria.
11. Personnel Training
i. Ensure that new employees, experienced employees and supervisors
are fully trained/qualified.
ii. Ensure that training requirements are defined in an approved SOP.
iii. Ensure that laboratory personnel are receiving both GMP and job skills
training and that it is documented.
12. Equipment and Instrumentation
i. Ensure that equipment and instrumentation (including software) are
qualified.
ii. Ensure that stickers indicating maintenance dates or repair are current
and that instruments not to be used are appropriately labelled.
iii. Ensure, upon completion of repair work, appropriate testing is
performed as outlined in an approved change control program.
iv. Ensure that the equipment list is accurate based on audit observations.
v. Ensure that all calibration procedures, whether internally or externally
performed, have been approved by appropriate site personnel.
vi. Ensure that calibration and maintenance is performed with sufficient
frequency to assure optimal operating conditions of each piece or
equipment or instrumentation.
vii. Ensure that there are approved and followed SOPs for maintenance,
calibration and change control.
viii. Ensure stickers or systems are available to verify
maintenance/calibration dates.
ix. Ensure that all repair and maintenance work has been documented.
x. Ensure that reference weights used for control of balances are checked
against national/international standards as appropriate.
13. Test method validation
i. Ensure that test methods have been validated.
ii. Ensure that there are SOPs directing the validation procedure/method.
14. Stability testing
i. Ensure that there is an approved formal stability testing program in
place.
Quality Assurance Department
Audit Training Manual
Title: AUDIT TRAINING MANUAL. Revision No. 00
Doc. No: Effective Date: Supersede Date: Review Date:
QA/ATM/001 07/06/2010 07/06/2012
ii. Ensure the site is in compliance with pull dates from the stability
testing program.
iii. Ensure that stability test chambers and conditions have been validated.
iv. Ensure that the testing performed for stability is appropriate and
adequate.
15. Reserve samples
i. Ensure reserve samples are held under conditions specified on their
label or as stated in approved retention period documentation.
ii. Ensure reserve samples use the same or similar container/closure
system as others in the same lot.
iii. Ensure that reserve samples are retained as appropriate.