six system management according to 21cfr

1. SEMINAR/ASSIGNMENT-I(MQA103T)
SIX SYSTEM OF INSPECTION MODEL
NAME:-VINIT NAI
M.PHARM(PQA) SEM 1
SUBJECT:-QUALITY MANAGEMENT SYSTEM
SUBJECT CODE :-MQA102T
GUIDED BY- FALGUN MEHATA
KRISHNA SCHOOL OF PHARMACY & RESEARCH(KSP)
1

2. Objective:-
 Inspection
 Objectives of inspection
 Purpose of inspection
 Six system inspection model
 Production system
 Facility and equipment system
 Laboratory control system
 Packaging and labeling system
 Quality management system
2

3. What is inspection?
Inspection:-
An inspection involves checking something, i.e.,
examining and assessing something.
Inspection in terms of Pharmaceutical industry : A quality
inspection involves measuring, examining, testing, various
characteristics of a product and comparing those results
with specified requirements to determine whether there is
a conformity.
3

4. Objectives of inspection
To detect and remove the faulty raw materials before it
undergoes production.
To detect the faulty products in production whenever it is
detected.
To bring facts to the notice of managers before they become
serious to enable them discover weaknesses and overcome the
problem.
To prevent the substandard reaching the customer and reducing
complaints.
To promote reputation for quality and reliability of product.
4

5. Purpose of inspection
To distinguish good lots from bad lots.
To determine if the process is changing.
To determine if the process is approaching the
specification limits.
To rate quality of product.
To measure the precision of the measuring instrument.
To measure process capability
5

6. Six system inspection model
 It is the FDA's Drug Manufacturing Inspection Compliance
Program, which contains instructions to FDA personnel for
conducting inspections, it is a systems-based approach for
inspection
 One of the important themes of the systems based inspection
compliance program is that you have the ability to assess whether
each of the systems is in a state of control.
 Pharmaceutical manufacturers should implement modern quality
systems with risk management approaches to meet the requirements
of the Agency's current good manufacturing practice (cGMP) as per
regulations 21 Code of Federal Regulations (CFR) parts 210 and
211.
6

7. Six system inspection model
The six systems referred to in this inspection model are:-
Quality System
Production System
Facilities and equipment system
Laboratory control system
Material system
Packaging and labeling system
7

8.  The diagram shows the correlation ship amongst the six systems: the
quality system and the five manufacturing systems, which appear to be
closely interrelated and inseparable during operations.
8

9. 1)Production System:-
This system includes measures and activities to control the
manufacture of drugs and drug products including
Batch compounding.
Dosage form.
ln -process sampling and testing.
Process validation.
It also includes establishing, following, and documenting
performance of approved manufacturing procedures.
9

10. Continue…
Batch numbering and maintaining proper traceability is
required/process validation is required. –Track batch,
equipment used records and labeling used, personnel , raw
material .
All batch records must be reviewed by QA.
Sampling and testing of in-process materials and drug
products.
Inspection is carry out according to the cGMP regulation,
21 CFR 211 Subparts B, F, and J.
Subpart B is for personnel
10

11. Subpart F:-Production and Process Controls
Written procedures; deviations.
Charge-in of components.
Calculation of yield.
Equipment identification.
Sampling and testing of in-process materials and drug
products.
Time limitations on production.
Control of microbiological contamination.
11

12. 2) Facility and equipment system
This system includes the measures and activities which provide
an appropriate physical environment and resources used in the
production of the drugs or drug products.
It includes:-
a) Buildings and facilities along with maintenance.
b) Equipment qualifications (installation and operation).
c) Equipment calibration and preventative maintenance.
d) Cleaning and validation of cleaning processes.
e) Inspection is carry out according to the cGMP regulation, 21
CFR 211 Subparts B, C, D, and J
12

13. Continue…
Subpart C-Buildings and Facilities:-
Design and construction features.
Lighting.
Ventilation, air filtration, air heating and cooling.
Sewage
Washing and toilet facilities.
Sanitation.
13

14. Subpart D-Equipment :-
Equipment design, size, and location.
Equipment construction.
Equipment cleaning and maintenance.
Automatic, mechanical, and electronic equipment.
14

15. 3)Laboratory control system
It includes the Measures and activities related to laboratory
procedures, testing, analytical methods development, validation/
verification.
As per schedule M :-
Quality Control Laboratories shall be independent of the
production areas.
Separate areas shall be provided each for physicochemical,
biological, microbiological or radio-isotope analysis.
Separate instrument room with adequate area shall be provided for
sensitive and sophisticated instruments employed for analysis.
15

16. Quality Control Laboratories shall be designed appropriately for
the operations to be carried out in them.
Adequate space shall be provided to avoid mix-ups and cross-
contamination.
Sufficient and suitable storage space shall be provided for test
samples, retained samples, reference standards, reagents and
records.
Inspection is carry out according to the cGMP regulation, 21 CFR
211 Subparts B, I, J, and K.
16

17. Subpart I - Laboratory Controls
General requirements.
Testing and release for distribution.
Stability testing.
Special testing requirements
Laboratory animals.
Penicillin contamination.
Subpart K - Returned and Salvaged Drug Products
Returned drug products.
Drug product salvaging.
17

18. Responsibilities of personals:-
Laboratory director:-
To ensure that laboratory develops and uses a quality
system approach to laboratory testing that provides
accurate and reliable patient test results.
Ongoing monitoring of each testing process used in
laboratory to identify potential problems that could result
in errors.
Lab technicians:-
To operate laboratory equipment and computers and
performs other assigned work, in accordance to document
laboratory procedures
Carry out sampling, testing, measuring, recording and
analyzing.
18

19. 4)Material system :-
This system includes measures and activities to control
finished products, components, containers and closures.
 Materials System Control of incoming materials and
components quarantine, storage, release, and use.
It includes:-
Receipt and storage of untested components
Drug product containers, and closure.
Testing and approval or rejection of components, drug
product containers, and closures.
19

20. Use of approved components, drug product containers,
and closures.
Retesting of approved components, drug products,
containers and closures.
Validation of computerized inventory control processes .
Drug storage, distribution controls, and records.
Inspection is done by:-21 CFR 211 subpart B,H,E and J
Subpart H :-holding and distribution
20

21. 5) Packaging and labeling system:-
This system includes measures and activities that control the
packaging and labeling of drugs and drug products.
There shall be written procedures designed to assure that correct
labels, labeling, and packaging materials are used for drug
products.
Any labeling or packaging materials meeting appropriate written
specifications may be approved and released for use
Any labeling or packaging material that do not meet such
specifications shall be rejected to prevent their use in operations
for which they are unsuitable.
Records shall be maintained for each shipment received of each
different labeling and packaging material indicating receipt,
examination or testing, and whether accepted or rejected..
21

22. Continue…
Packaged and labeled products shall be examined during
finishing operations to provide assurance that containers and
packages in the lot have the correct label.
A representative sample of units shall be collected at the
completion of finishing operations and shall be visually examined
for correct labeling. Results of these examinations shall be
recorded in the batch production or control records.
Obsolete and outdated labels, labeling, and other packaging
materials shall be destroyed.
Procedures shall be used to reconcile the quantities of labeling
issued, used, and returned, and shall require evaluation of
discrepancies.
Inspection done by 21 CFR 211 subpart B,G and J
22

23. 6)Quality management system:-
A Quality Management System is a collection of policies,
procedures, plans, resources, processes, practices, and the
specification of responsibilities.
It is designed to achieve product and service quality levels,
customer satisfaction and company objectives.
The system includes the quality control unit and all of its
review and approval duties (e.g., change control,
reprocessing, batch release, annual record review,
validation protocols, and reports, etc.).
It includes all product defect evaluations and evaluation of
returned and salvaged drug products.
23

24.  Inspection is carry out according to cGMP regulation, 21 CFR 211
Subparts B, E, F, G, I, J, and K.
 Subpart B – Organization and Personnel.
 Responsibilities of quality control unit.
 Personnel qualifications.
 Personnel responsibilities.
 Consultants
 Subpart E –Control of Components and Drug Product Containers
and Closures.
 General requirements
 Receipt and storage of untested components, drug product containers,
and closures.
 Testing and approval or rejection of components, drug product
containers, and closures.
 Use of approved
24

25. Subpart F – Production and Process Control
Written procedures; deviation .
Calculation of yield.
Subpart G – Packaging and Labeling Control
Materials examination and usage criteria.
Labeling issuance.
25

26. References:-
 https://www.slideshare.net/vaishalidandge1/six-system-inspection-model-
249396156
 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfmcfrpart=2
26

27. THANK
YOU
27