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Internal Audit or Self Inspection Defects and Regulatory Compliance
Check List
Learn the critical, major and minor defects found during internal audit in Pharmaceuticals and
self inspection compliance check list.
Ankur Choudhary
|
Audit | Quality Assurance Be the first to comment!
Following types of defects were identified during internal audit and these
are helpful in regulatory compliance:
1. Critical defect:
Critical defects have a high probability of resulting in product recall or in an adverse
physiological response by the consumer. Critical deficiencies found in internal audits that usually
produce significant effects on the strength, identity, safety and purity of the product that will be
considered during regulatory compliance.
Possible source of critical defect:
• Cross contamination of materials of product
• Incorrect labeling
• Active ingredients outside of specifications
• Product manufactured according to obsolete or unapproved procedures
• Open sterile products located in non-aseptic area
• Untrained operators working in sterile filling area
• Contaminated purified water or water for injection system
2. Major defect:
Major defects found during internal audit can reduce the usability or stability of a product, but
without causing harm to the consumer.
Possible source of major defect:
• Major equipment not calibrated or out of calibration
• Inadequate segregation of quarantine components
• Inadequate evaluation of production process outside of action levels
• Process deviations not properly documented or investigated
• Operator not trained in or familiar with the standard operating procedures
• Preventive maintenance on a critical water system not conducted according to schedule
• Lack of standard operating procedures for cleaning equipment.
• Audits of a contract manufacturer not conducted
3. Minor defect:
Minor defects have a low probability of affecting the quality or usability of the product which
can help in regulatory compliance.
Possible source of minor defect:
• Failure to complete all batch record entries
• Warehouse not cleaned according to schedule
• Cracks in wall surfaces
• Failures to correct documentation errors properly
• Operator uniform not properly worn
• Standard operating procedure review is overdue
• Adhesive tape used on manufacturing equipments
• Laboratory buffer solutions are obsolete
Related: How to plan for a GMP audit
SELF INSPECTION COMPLIANCE CHECK LIST:
The results of check list highlight as a grading system, i.e. 1, 2,3,4,5. Here 1 = yes; 2 =
unnecessary; 3 = partial; 4 = no; 5 = in doubt.
S. No.
Check list questions
Results
1
2
3
4
5
Personnel
1. Name of expert responsible for production ……….
2.
Does he have the required qualifications, knowledge
and practical experience?
3.
Is he competent?
4.
Is he a full-timer?
5.
Name of expert responsible for quality control …......
6.
Does he have the required qualifications, knowledge
and practical experience?
7.
Is he competent?
8.
Is he a full-timer?
Premises
9.
Are sufficiently large and separated areas available
for
Receiving of materials?
10.
Are sufficiently large and separated areas available
for Raw materials storage?
11.
Are sufficiently large and separated areas available
for Packaging materials storage?
12.
Are sufficiently large and separated areas available
for Processing?
13.
Are sufficiently large and separated areas available
for Packaging?
14.
Are sufficiently large and separated areas available
for Bulk product storage?
15.
Are sufficiently large and separated areas available
for Finished product storage?
16.
Are sufficiently large and separated areas available
for Storage of high toxic drug products and narcotics?
17.
Are premises provided with sufficient lighting,
ventilation and air conditioning?
18.
Are air-borne microbial counts of the areas checked
regularly?
19.
Are records of the microbial count kept? Etc.
Equipment
20.
Are they suitable for their intended use?
21.
Can they be easily and thoroughly cleaned?
22.
Are operating conditions of sterilizer controlled
according to SOP?
23.
Are equipment cleaned with approved method at
regularly intervals?
24.
Are equipment for aseptic processing
microbiologically checked with approved method at
regular intervals?
Sanitation
25.
Are production areas Clean?
26.
Are production areas Free of accumulated waste?
27.
Are written sanitation program available for Areas to
be cleaned?
28.
Are written sanitation program available for Objects
and intervals of cleaning?
29.
Are well ventilated toilets and hand washing
facilities?
30.
Are gowning rooms and break room?
Starting materials
31.
Are all records of starting materials kept?
32.
Do the records specify the origin of starting
materials?
33.
Do the records specify the date of receipt?
34.
Do the records specify the date of release?
35.
Do the records specify the drug product and batch
number for which the starting material is used
36.
Are containers labeled properly?
37.
Are containers not damaged?
38.
Are containers stored properly?
39.
Are samples of starting materials checked by Q.C?
40.
Are they secured in quarantine before release?
41.
Are rejected starting materials distinctly identified
and handled according to their quality?
Production operations
42.
Are all equipment used only in the relevant area?
43.
Are aseptic operations carried out in special area?
44.
Is adequate exhaust system provided for potent drug
manufacturing area?
45.
Are sterile area protected with a technique such as a
laminar air flow?
46.
Are sterile area protected by compulsory disinfection
of hands prior to gowning and entering the relevant
special area?
Production personnel
47.
Do the production personnel undergo periodical
health check?
48.
In handling of hazardous materials, do they wear
protective clothing?
49.
In handling of hazardous materials, do they wear
respiratory mask?
Production procedures
50.
Do production procedures describe the name and
dosage form?
51.
Do production procedures describe identifications of
end containers, packaging materials and labels?
52.
Do production procedures describe the theoretical
yield for every production step?
53.
Do production procedures describe acceptable yield
limits?
Batch processing records
54.
Is a processing record for any batch available?
55.
Is a complete instruction of the relevant batch
processed according to the master formula?
56.
Is a name and dosage form?
57.
Is a date of manufacture?
58.
Is a complete formula?
59.
Are records on all in-process controls and of results
obtained?
60.
Is sample or identification of packaging materials?
61.
Is enclosed detailed analytical reports?
Labeling and packaging
62.
Is entry to packaging materials storage room
restricted only to authorized persons?
63.
Are packaging materials checked and released before
use?
64.
Are packaging materials issued only against written
orders?
65.
Are packaging materials actual quantity delivered as
requested?
66.
Are packaging materials checked prior to use?
67.
Are measures taken to prevent packaging errors?
68.
Does the packaging identification contain all data
required by law?
69.
Does the packaging identification contain batch
number?
70.
Does the packaging identification contain expiry
date?
71.
Does the packaging identification contain other
necessary details?
Quality Control system
72.
Is quality control performed by the company itself?
73.
Is quality control carried out by a unit independent
from production?
74.
Is the quality control organization autonomous in
responsibility?
75.
Is the quality control organization provided with
sufficiently trained personnel?
76.
Is the quality control organization provided with
sufficient equipment to perform required controls?
77.
Is the quality control organization headed and
supervised by an expert?
78.
Does the expert hold final responsibility to release or
reject any product/material tested?
79.
Does the unit elaborating detailed instruction in
writing for testing and analysis implementation?
80.
Does the unit test, release or reject intermediates and
bulk products?
81.
Does the unit test, release or reject finished products?
82.
Does the unit test, release or reject packaging
materials?
83.
Does the unit evaluating storage conditions?
84.
Does the unit carry out stability tests?
85.
Does the unit establishing expiration dates and
storage regulations based on shelf life?
86.
Are sampling performed according to approved
procedure?
87.
Are retained samples properly labeled?
88.
Are analysis record kept?
89.
Does this analysis contain a final conclusion on
whether the tested batch meets specification?
Self-inspection
90.
Are regular self-inspections carried out according to
GMP-guidelines?
91.
Are results of self-inspections recorded?
Distribution
92.
In the event of a recall is the distribution of a batch
traceable?
93.
Are records of distribution kept?
Complaints and reports
94.
Are complaints conveyed to the responsible person in
the company?
95.
Are complaints forwarded to offices outside the
company, if necessary?
96.
Are complaints checked regularly?
97.
Are relevant action taken?
98.
Are records of complaints kept according to drug
product group?
Also see: Self Inspection and Quality Audits
Submitted by:
Md. Abdul Bake
Pharmacist, Hospital Sales
Sanofi-aventis Bangladesh Ltd.
Email: abdul.bake@yahoo.com