Presentation of QUALITY CONTROL AND QUALITY ASSURANCE-Unit 5 (Self-selected Topics)Introduction Sec. 211.101 charge-in of components. Sec. 211.134 drug product inspection. Sec. 211.115 reprocessing.

1. PRESENTATION
OF
QUALITY CONTROL AND QUALITY
ASSURANCE
UNIT 5
(SELF SELECTED TOPICS)
NAME: ANANT NAG
ID: MPH/10016/21
SUBJECT: QUALITY CONTROL AND QUALITY
ASSURANCE
(MQA 103T)

2. CONTENT
1. Introduction
2. Sec. 211.101 charge-in of components.
3. Sec. 211.134 drug product inspection.
4. Sec. 211.115 reprocessing.

3. INTRODUCTION
Title 21 of the CFR or the Code of Federal
Regulations deals with governing of food and
drugs in the United States for three of its
governing bodies:
 The FDA (Food and Drug Administration),
 DEA (Drug Enforcement Agency)
 ONDCP (Office of National Drug Control
Policy).

4. 21 CFR PART 211
Compliance requires the manager of any
regulatory controlled manufacturing
company to manufacture all medicinal
products so as to ensure that they are fit
for their intended use, comply with the
requirements of the marketing
authorization and do not place patients at
risk due to inadequate safety, quality or
efficacy.

5. The attainment of this 21 CFR Part 211
compliance is the responsibility of senior
management and requires the participation
and commitment by staff in many different
departments and at all levels within the
company, by the company’s suppliers and
by the distributors.

6. TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C - DRUGS: GENERAL
PART 211 -- CURRENT GOOD MANUFACTURING
PRACTICE FOR FINISHED PHARMACEUTICALS
Subpart F - Production and Process Controls
Sec. 211.101 Charge-in of components.

7. Written production and control
procedures shall include the following,
which are designed to assure that the drug
products produced have the identity,
strength, quality, and purity they purport
or are represented to possess.

8. (a) The batch shall be formulated with the
intent to provide not less than 100 percent
of the labeled or established amount of
active ingredient.
(b) Components for drug product
manufacturing shall be weighed,
measured, or subdivided as appropriate.

9. If a component is removed from the original
container to another, the new
container shall be identified with the
following information:
1. Component name or item code;
2. Receiving or control number;
3. Weight or measure in new container;
4. Batch for which component was
dispensed, including its product name,
strength, and lot number.

10. (c) Weighing, measuring, or subdividing
operations for components shall be
adequately supervised. Each container of
component dispensed to
manufacturing shall be examined by a
second person to assure that:

11. 1. The component was released by the quality
control unit;
2. The weight or measure is correct as stated in
the batch production records;
3. The containers are properly identified. If the
weighing, measuring, or subdividing
operations are performed by automated
equipment under § 211.68, only one person is
needed to assure paragraphs (c)(1), (c)(2), and
(c)(3) of this section.

12. (d) Each component shall either be added to
the batch by one person and verified by a
second person or, if the components are
added by automated equipment under §
211.68, only verified by one person.

13. TITLE 21--FOOD AND DRUGS
CHAPTER I - FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C - DRUGS: GENERAL
 PART 211 -- CURRENT GOOD MANUFACTURING
PRACTICE FOR FINISHED PHARMACEUTICALS
 Subpart G - Packaging and Labeling Control
 Sec. 211.134 Drug product inspection.

14. (a) Packaged and labeled products shall be
examined during finishing operations to
provide assurance that containers and
packages in the lot have the correct label.

15. (b) A representative sample of units shall be
collected at the completion of finishing
operations and shall be visually examined
for correct labeling.

16. (c) Results of these examinations shall be
recorded in the batch production or control
records.

17. TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C - DRUGS: GENERAL
PART 211 -- CURRENT GOOD MANUFACTURING
PRACTICE FOR FINISHED PHARMACEUTICALS
Subpart F - Production and Process Controls
Sec. 211.115 Reprocessing.

18. (a) Written procedures shall be established
and followed prescribing a system for
reprocessing batches that do not conform
to standards or specifications and the steps
to be taken to insure that the reprocessed
batches will conform with all established
standards, specifications, and
characteristics.

19. (b) Reprocessing shall not be performed
without the review and approval of the
quality control unit.

20. REFRENCES
1. https://www.law.cornell.edu/cfr/text/21/211.10
1
2. https://www.accessdata.fda.gov/scripts/cdrh/cf
docs/cfcfr/CFRSearch.cfm?fr=211.134#:~:text
=Sec.,lot%20have%20the%20correct%20label.
3. https://www.accessdata.fda.gov/scripts/cdrh/cf
docs/cfcfr/CFRSearch.cfm?fr=211.115

21. THANK YOU