Six System Inspection Model (QMS)

1. PRESENTED BY:- URVI PATEL

2.  According to ISO 19011, Guidelines for Auditing Quality Systems,
defines a quality audit as a
systematic, independent and documented process for obtaining audit
evidence(records, statements of facts or other information, which are
relevant to the audit criteria and verifiable) and evaluating it objectively to
determine the extent to which the audit criteria (set of policies,
procedures or requirements) are fulfilled.
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3. COMPONENTS
OF SIX
SYSTEM
INSPECTION
MODEL
Quality
System
Production
System
Facility &
Equipment
System
Laboratory
Control
System
Material
Control
Packaging
&
Labelling
System
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4.  The goal of this section is to describe a model for use in pharmaceutical
manufacturing that can help manufacturers comply with the CGMP
regulations.
 It should be noted that implementing an effective quality system in a
manufacturing organization will require a significant investment of time
and resources.
 This system includes quality control unit and all of its review and
approval duties.
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5.  The firm should have written and approved procedures and documents
which are inspected in this system.
A. Product reviews.
B. Complaint reviews.
C. Discrepancy and failure investigations related to manufacturing and
testing.
D. Change control.
E. Production improvement project.
F. Returns and salvages.
G. Stability failures.
H. Validation.
I. Training/qualification of employees in quality control unit functions.
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6.  This system includes measures and activities to control the
manufacture of drug and drug products including- batch compounding,
dosage form production, in-process sampling and testing, process
validation.
 Inspection carried out according to cGMP regulation, 21CFR 211
subparts B, F and J.
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7. A. Written procedures.
B. Charge in components.
C. Calculation of yield.
D. Equipment identification.
E. Sampling and testing of in-process materials and drug products.
F. Control of microbiological contamination.
G. Time limitations on production.
H. Reprocessing.
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8.  This system includes the measures and activities which provide an
appropriate physical environment and resources used in production of
drug and drug products.
 Inspection carried out according to cGMP regulation, 21CFR 211
subparts B,C,D and J.
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9. A. Design and construction features.
B. Lighting.
C. Ventilation, air filtration, air heating and cooling.
D. Plumbing.
E. Sewage and refuse.
F. Washing and toilet facilities.
G. Sanitation.
H. Equipment design, size, and location.
I. Equipment construction.
J. Equipment cleaning and maintenance.
K. Automatic, mechanical, and electronic equipment.
L. Filters.
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10.  This system includes measures and activities related to laboratory
procedures, testing, analytical method development, validation, stability
program.
 cGMP regulation include, 21CFR 211 Subpart B,I,J and K
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11. A. General requirements.
B. Testing and release for distribution.
C. Stability testing.
D. Special testing requirements.
E. Reserve samples.
F. Laboratory animals.
G. Penicillin contamination.
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12.  This system includes measures and activities to control finished
products, components including water or gases that are incorporated
into the product, containers and closures.
 It includes validation of computerized inventory control processes, drug
storage, distribution control, records.
 cGMP regulation- 21CFR 211 subparts B, E, H and J
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13. A. General requirements.
B. Receipt and storage of untested components, drug product
containers, and closures.
C. Testing and approval or rejection of components, drug product
containers, and closures.
D. Use of approved components, drug product containers, and closures.
E. Retesting of approved components, drug product containers, and
closures.
F. Rejected components, drug product containers, and closures.
G. Drug product containers and closures.
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14.  This system includes measures and activities that control the packaging
and labelling of drug and drug products.
 Inspection carried out according to cGMP regulation, 21CFR 211
subparts B,G and J.
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15. A. Materials examination and usage criteria.
B. Labelling issuance.
C. Packaging and labelling operations.
D. Drug product inspection.
E. Expiration dating.
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16.  Principle : The purpose of self-inspection is to evaluate the
manufacturer’s compliance with GMP in all aspects of production and
quality control.
 The self inspection programme should be designed to detect any
shortcomings in the implementation of GMP and to recommend the
necessary corrective actions.
 All recommendations for corrective action should be implemented.
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17. Self-inspection team
 Management should appoint a self-inspection team consisting of
experts in their respective fields and familiar with GMP. The members of
the team may be appointed from inside or outside the company.
Frequency of self-inspection
 The frequency at which self-inspections are conducted may depend on
company requirements but should preferably be at least once a year.
The frequency should be stated in the procedure.
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18. Self-inspection report
 A report should be made at the completion of a self-inspection. The
report should include: (a) self-inspection results;
(b) evaluation and conclusions;
(c) recommended corrective actions
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19.  Thomas Pyzdek, Paul Keller, The Handbook For Quality Management-
A complete guide to operational excellence, 2nd Edition, Page no. 211
 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211
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20. THANK YOU
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