FINISHED PRODUCT RELEASE, QUALITY REVIEW, QUALITY AUDIT AND BATCH RELEASE DOCUMENT prepared by s.susena,ssj college of pharmacy

1. FINISHED PRODUCT RELEASE,
QUALITY REVIEW, QUALITY AUDIT
AND BATCH RELEASE DOCUMENT
Prepared By: S.SUSENA
( M. Pharm Sem-2)
Q.A . Department
Guided by: Nansri saha
S. S. J. Pharmacy College

2. Agenda:
 Finished Product Release
 WHO Guideline
 SOP on Releasing of Finished Product
 Sampling & Testing
 Quality Review
 Quality Audit
 Batch Release Document
2

3. FINISHED PRODUCT RELEASE:
• A Product in the marketable pack is
classified as finished product.
• Practically a transportable pack, i.e. a
shipper containing the salable pack (in
retail) is considered the finished product
3

4. WHO Guidelines :
• Finished product should be held in
quarantine until their final release, after
which they should be stored as usable stock
under conditions established by the
manufacturer.
• Product failing to meet the established
specifications or any other relevant quality
criteria should be rejected.
4

5. SOP on Releasing of Finished Product:
• SOP on releasing product should address the following
points:
• Who is the authority to release a batch? He may be:
– a. “Authorised person” as per regulatory requirements,
– b. QA head, or
– c. Any other person suitably Authorised for this purpose.
• II.Before releasing the finished product at least following
points should be considered:
– a. Completed B. P. C. R.
– b. Test reports of I. P. Q. C.
– c. Test reports of finished product / analysis.
– d. Deviations reports if any.
– e. Sterility reports.
5

6. Sampling:
• Sampling is a procedure for collecting a
‘sample’ and ‘sample’ means a small part or
quantity intended to show what the ‘whole’
• Major activities of QC.
• Acceptance Sampling: It may be defined as
the process of evaluating a portion of the
product in a lot for the purpose of accepting
or rejecting the entire lot as either
conforming or not conforming to a quality
specifications.
6

7. Sampling techniques:
1. No Inspection.
2. Small Samples.
3. Large Samples.
4. 100% Inspections
7

8. Sampling Risks:
• Good lots can be rejected.This is called the
Producer’s risk.
• Bad lots can be accepted. This is called the
consumer’s risk
8

9. Sampling Plans:
• Attributer Plans : A random sample is
taken from the lot and each unit is classified
as acceptable or defective.
• Variable Plans : A sample is taken and a
measurement of a specified quality
characteristics is made on each unit from
lot.
9

10. 5/19/2013
Free template from www.brainybetty.com
(copyright 2007)
10

11. DOCUMENTS RELATED TO FINISHED PRODUCT
RELEASE
• Laboratory investigation and report form
• Finished good cards
• Stability Data
• Master document Change control form
• Retention sample log book
• Test sample log book
• QA inspection Sheet
• Finished Product specification& test report
• Calibration policies and related reports
• Reference substance specification report
• Laboratory Work Book
• Managing Analytical reagent
• Stability& trail testing procedure
• Laboratory Waste management
• Laboratory Results- Out of specification investigation reports
11

12. Finished Product Register:
• LAB NO:
• BATCH PRODUCTION
• Product name
• Manuf.date
• Container
• Batch size
• Goods booking slip no:
• Comment
• Date passed
• Lab/ Qa sign
12

13. 5/19/2013
Free template from www.brainybetty.com
(copyright 2007)
13

14. 5/19/2013
Free template from www.brainybetty.com
(copyright 2007)
14

15. FLOW CHART OF FINISHED PRODUCT -
INSPECTION
5/19/2013
Free template from www.brainybetty.com
(copyright 2007)
15

16. Quality Review
• Before a finished product is released for sale
or distribution, the complete production
and control records must be reviewed and
assured satisfaction about the entire
process of production and control.
• This is considered to be the last stage in the
control process before the product moves
out of the manufacturing premises
16

17. Problems in Investigations:
• Investigating Officer
• Training Planning
• Witness Interviews
17

18. Investigating Officer Training:
• Formal training by the Inspector
• Investigation requirements
• Judge Advocate participation
18

19. Advance Planning:
• Road map - Where do you want to go?
• Brainstorm with Inspector
a. Identify document needs
b. Prepare witness list
c. Prepare questions
19

20. Witness Interviews:
• Use outline of questions
• Ask the tough questions
• Listen to the answers and follow-up
• Follow procedural requirements
• Explain absence of necessary witnesses
20

21. Quality review should be seen as a 3 phase
process:
• Phase 1-Preparation:
• This phase precedes the actual review
meeting
• It is the responsibility of the chairman and
presenter to organize the quality review and
notify all those invited.
21

22. Phase 2- The review meeting:
22
• The central phase of the quality review process is
the review meeting itself
• During the review meeting the emphasis should
be on error detection, in line with the criteria,
and only limited discussion of corrective action
should occur

23. Phase 3- The Follow-Up
• Following the quality review meeting there
should be a follow-up period during which
the errors identified at the review that were
committed to the follow-up action list are
rectified and signed off
23

24. QUALITY AUDIT
• It is defined as “A systematic and
independent examination to determine
whether quality activities and related
results comply with planned arrangements
and whether these arrangements are
implemented effectively and are suitable to
achieve objectives
24

25. OVERVIEW OF TYPICAL AUDIT
ACTIVITIES
• INITIATING THE AUDIT
• CONDUCTING DOCUMENT REVIEW
• PREPARING FOR ON-SITE AUDIT ACTIVITIES
• CONDUCTING ON-SITE AUDIT ACTIVITIES
• PREPARING, APPROVING AND DISTRIBUTING THE
AUDIT REPORT.
• COMPLETING THE AUDIT
• CONDUCTING THE AUDIT FOLLOW-UP. 25

26. PRINCIPLES OF AUDITING
• ETHICAL CONDUCT:
• FAIR PRESENTATION:
• DUE PROFESSIONAL CARE:
• INDEPENDENCE:
• EVIDENCE BASED APPROACH
26

27. • TYPES OF AUDIT:
• Firstly the audits may be classified as :
1. Internal auditing.
2. External auditing
) 27

28. INTERNAL AUDITING:
• Internal Quality Audit will be conducted by
a team of Pharmaceutical Laboratory
personnel drawn from all laboratory areas.
• EXTERNAL AUDITING: carried out by a
company on its vendors or subcontractors.
There is no legal requirement to conduct
such audits, but the need is implicit, since
manufacturers are required to have a
thorough knowledge of their suppliers.
28

29. GOALS OF GMP AUDITING
• -Determine whether QA, production activities
and systems comply with GMPs, regulatory
agency requirements and site requirements.
• -Facilitate early detection of problems.
• -Help determine the depth of the identified
problem in the area as well as across the
company.
• -Investigate and determine the root cause of
the problem/deficiency. 29

30. ROLE OF AUDITOR:
• There are two necessary components for an
audit to be successful.
– The first is an auditor with the right skills,
education and experience.
– The second is the audit process itself.
• The auditor is a key component of the audit.
To increase the effectiveness of the audit,
the auditor must have good auditing
practices and techniques that will:
30

31. AUDIT CHECK- LIST
1 .Documentation work.
2 .QA/QC Issues.
3.SOP Manuals.
4 .Building and Facilities.
5.Failure Investigation.
6.Process Validation Program.
7.Master Records.
8.Production and In-Process controls.
9.Packaging and labelling of API’s and Intermediates.
10.Equipment Processing.
11.Storage and Distribution.
12.Material Management.
13.House keeping facilities.
31

32. BATCH RELEASE DOCUMENT
• All relevant paperwork for a particular
batch, including samples of printed cartons,
leaflet, shipper labels, Line Openings, Line
Clearances records, etc. and collecting them
together.
• There should be written procedure for the
distribution of each batch of a product to
facilitate recall of the batch
32

33. • The distribution record should include at least
the following data:
• name, address and number of the customer that
the product is shipped to: -
• delivery order delivered date and number:-
• name, dosage form and strength of the product-
• Quantity-
• Product batch number-
• Expiry date-
• Special storage requirement or precautionary
measures to handle the product. . 33

34. CONCLUSION:
• Here by conclude that finished product is a
medical product which has under gone all
stages of production including packaging
• Quality reviews are planned and
documented inspections of a review item
• Audit checks are the information gathering
activity which potentially identifies the
problems in implementation of quality
standard in an organization
34

35. REFERENCES:
1. Quality assurance and quality management in
pharmaceutical industry by Y.Anjaneyulu and
R.Marayya.
2. GMP for Pharmaceuticals, by Manohar A Potdar.
3. Quality Manual, by D. H. Shah
4. Good Manufacturing Practices for Pharmaceuticals, vol.
109 , Marcel Dekkar Inc., N. Y.
5. www. who.int
6. www.pharmaquality.com
7. www.fda.com
35