Documentation with respect to release of finished pharmaceutical product

DOCUMENTATION WITH RESPECT TO
RELEASE OF FINISHED PHARMACEUTICAL
PRODUCT
1
-MADHURA NEWREKAR
M. PHARM (QA)

Contents
Documentation -Introduction
Finished product
Finished product release procedure
Documents related to finished product release
SOPs related to finished product release
Complaints concerning defective products
2

1.Documentation and need for
documentation
O Proper documentation and its maintenance is a
principle step in GMP. It is a crucial part of the
quality assurance system and is needed in every
aspect of pharmaceutical manufacturing.
O Proper records permit to keep track over the
manufacturing of particular batch , starting from
receipt of raw materials to the final product
release.
O It gives us an evidence or assurance that the
manufacturing procedure or quality related
activities are carried out in the similar manner as
they are planned and approved. 3

Continued…
O Documentation is an authenticated proof of
GMP compliance.
O GDoP : Good documentation practice. It is a
term used to describe standards by which
documents are created and maintained,
4

5
Finished product

2.Finished product
6
O As per WHO guidelines ,
product which has
undergone all the stages
of production including
packaging.
O A product in marketable
pack.
O Practically a
transportable pack
,containing ready to use
formulations which
doesn’t need further
processing.

2.1 WHO guide
lines for finished product
O Finished product should be held in
quarantine until their final release ,after
which they are stored as per the
conditions established by the
manufacturer.
O The products failing to meet the
established specifications or any other
relevant quality criteria should be rejected.
7

2.2 Finished product register
1.Lab No
2.Product name
3.Manufacturing date
4.Container
5.Batch size
6.Goods booking slip no
7.Date passed
8.Lab/QA sign
8

9
Finished product

3.Finished product release
O Finished product inspection procedure:
10
Completion of batch of finished
product
Sampling by QA
Under test
QC testing
Preparation of report
• Approved –released
• Failed- Hold or rejected

3.1 Sampling of a finished
product
O Sampling is a procedure for collecting a ‘sample’
and a ‘sample’ means a small part or quantity
intended to show or represent the ‘whole’ of the
lot.
O Acceptance sampling: It may be defined as a
process of evaluating a portion of the product in
a lot for the purpose of accepting or rejecting an
entire lot as either confirming or not confirming to
quality specifications.
11

Sampling plans and risks
O Attributor plans: A random sample is taken from
a lot and each unit is classified as acceptable or
defective.
O Variable plans: A sample is taken and
measurement of specified quality characteristics
is made on each unit from lot.
O Sampling risk:
O Producer’s risk: Good lots can be rejected.
O Consumer’s risk: Bad lots can be accepted.
13

3.2 Quality Review
O Before a finished product is released for
sale or distribution ,the complete
production and control records must be
assured or reviewed .
O This is considered to be a last stage in the
control process before the product moves
out of the manufacturing premises.
14

Steps of Quality Review
O Preparation: This phase precedes the
actual review meeting. It is the
responsibility of the chairman to organize
the quality review.
O The review meeting: The central phase is
review meeting itself. During the review
meeting the emphasis should be on error
detection and discussion about corrective
actions to be made.
O The follow up: The errors identified at the
review are rectified and signed off.
15

16
Finished product

4. Documents related to
finished product release
1.Stability data
2.Laboratory workbook
3.Certificate of analysis
4.Test and retention sample log book
5.Calibration policies
6.Master formula record (MFR)
7.Master document change control form
8.Deviation report
17

O Continued…..
9.Finished product and reference substance
specification report
10.Out of specification investigation report
11.QA inspection sheet
12.Stability and trial testing procedure
13.Information of analytical reagent
14.Batch manufacturing record (BMR)
18

Importance of documents
TRACEABILITY
VALID
EVIDENCE
GMP
COMPLIANCE
19

Maintenance of documents
O Records should be completed at time of
activity or when any action is taken.
O Superseded documents should be retained
for a specific period of time.
O Records should be retained for at least one
year after the expiry date of the finished
product.
20

4.1 Stability data:
All the stability tests of API , excipients and
preformulation with results are included.
4.2 Laboratory workbook:
It is a data entry by a laboratory personnel. It
includes name ,batch number ,testing date and all
raw data, equipment system , any protocol ,
column serial number for HPLC and GC.
Periodic reviews are carried out and internal or
external auditors may also randomly audit
workbooks.
This is the link between any analytical work and
any internal reports or reports to the regulatory
authorities. 21

4.3 Certificate of analysis(COA):
A certificate of analysis is a document issued
by a quality assurance team that confirms that a
regulated product meets its product
specifications.
It contains the actual results of tests performed
of an individual batch of product.
22

4.4 Test and retention sample log book:
Retention sample : A sample of a fully packaged
unit from a batch of finished product stored for
identification purposes.
In many cases , reference and retention samples of
finished products are presented identically.
We have to ensure that sample is retained in the
same packaging in which it is sold to the consumer.
24

4.5 Calibration policies and related reports:
The engineering department should identify the
critical and non critical instruments. The
frequency shall depend upon the criticality of
instruments.
The type of instruments is classified in two
categories. Instruments that are calibrated in
house and the instruments that are calibrated
by external agencies.
In case of in house calibration , head of QC
/QA/production/engineering is responsible to
ensure that the calibration is performed using
certified standards traceable to national or
international standards.
26

4.6 Master formula record(MFR) :
WHO identifies manufacturing instructions as
‘Master Formula’ .Individual companies may
give internal names to these documents
(manufacturing instructions ,monographs etc )
As per WHO GMP guidelines a formally
authorized master formula should exist for
each product and batch size to be
manufacturing.
28

4.7 Master document change control form:
Approved master document is an original
signed document .The approved signature
indicates approval for issuance and use.
Change control refers to a formal process used
to ensure that changes to a controlled document
are introduced in a controlled and coordinated
manner.
29

4.8 Deviation report
As per WHO guidelines , Deviation is
Planned or unplanned deviation
Different levels of deviation: critical ,major ,minor
31
A departure from standard practices or specifications
resulting in non-conforming material or processes with
potential to impact on product quality , safety ,efficacy or
data integrity.

4.9 Finished product specification report and
Reference substance specification report:
This document will include all the product
attributes such as name of product ,APIs,
formula , dosage form description
,qualitative and quantitative requirements
with acceptance limits , storage conditions
and precautions where applicable and shelf
life.
For reference substances , specifications
are appearance , melting point ,purity ,water
content ,microbial content.
33

4.10 Out of specification investigation report:
This guideline applies whenever a lab test result is
out of specification(OOS). It applies to physical and
chemical testing.
4.11 QA inspection sheet:
There is a separate check list for QA including
factory audit, in production check and final random
inspection.
35

4.12 Stability and trial testing procedures:
When a batch is set down for stability studies ,
the details are filled on stability/trial card.
4.13 Information about analytical reagents:
Technical grade or laboratory grade reagents are
of lowest quality.
ACS reagent grade conforms to specifications
defined by the committee on analytical reagent of
American Chemical Society. 36

4.14 Batch manufacturing record(BMR):
A good BMR should contain following parts:
 Batch record: batch no. ,batch size, composition,
weight of the batch, master formula referred, shelf
life ,storage conditions ,manufacturing license no.,
manufacturing date, expiry date, date of starting
and date of completion.
 General instructions for manufacturing
 Equipment cleaning record
 Bill of materials
 Manufacturing process
 Yield
 Abbreviations
 History of changes
37

38
Finished product

SOPs related to finished
product release
39

42
Finished product

6. Complaints concerning
defective products
All decisions made and actions taken as a result of
complaints should be recorded and referenced to
the corresponding batch documents.
Product recalls and handling:
O There should be a system to recall from the
market, promptly and effectively, products known
or suspected to be defective.
O An instruction should be included in the written
procedures to store recalled products in a secure
segregated area while their fate is decided.
43

O The progress of the recall process should
be monitored and recorded.
O Records should include the disposition of
the product. A ﬁnal report should be
issued, including a reconciliation between
the delivered and recovered quantities of
the products.
44

References
O https:// www.slideshare.net ,finished product
release , quality review ;May 19,2013.
O https:// www.pharmaguidelines.com;
accessed on 17/7/17.
O https://m.authorstream.com/presentation/sus
ena-1820085-ppt/; accessed on 17/7/17.
O https://www,gmp-publishing.com/batch-
release ; accessed on 17/7/17.
O aaps.who.int ,Good manufacturing practices.
45

O Quality assurance of pharmaceuticals ;a
compendium on guidelines and related
materials ; volume 2 ;second updated
edition ; World Health Organization.
O apps.who.int ; Good Documentation
Practices
O Apps.who.int ; Finished Pharmaceutical
Product specifications
46

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