How to read and write a quality control report

How to read and write a quality
control report
Alongside efficacy and safety, the quality of new and
marketed drug products is one of the predominant
requirements laid down by the rules governing drug
manufacture and approval of new medicines.
Quality Control(Drug monitoring):
All measures taken, including the setting of specification
sampling, testing and analytical clearance, to ensure that raw
materials, intermediates, packaging materials and finished
pharmaceutical products conform with established
specifications for identity, strength, purity and other
characteristics.
Quality control (QC) has to ensure the constant reproducible
characteristics of drugs in all parts of the world in order to
guarantee pharmacodynamic effects in all patients. QC plays an
important role in exactly elaborating, defining and refining quality
specifications and appropriate testing methods. There is a
long-established approach to compiling the specifications of
pharmaceutical products employing “official” methods including
pharmacopoeial methods, validated analytical procedures
provided by the manufacturer and approved by the relevant
government or validated analytical procedures developed by the
laboratory.
National pharmaceutical quality control
laboratories:
The government, normally through the national
medicines regulatory authority (NMRA)-in Egypt the ministry
of health -must establish a pharmaceutical quality control
laboratory to carry out the required tests and assays to verify
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that pharmaceutical active ingredient, excipients and final
products meet the prescribed specifications.
Throughout the process of marketing authorization and post
marketing surveillance, the laboratory work closely with the
NMRA.
A national pharmaceutical quality control
laboratory:
provides effective support for NMRA acting together with
its inspection services. The analytical results obtained should
accurately describe the properties of the samples assessed,
permitting correct conclusions to be drawn about the quality
of the samples of medicines analyzed, and also serving as an
adequate basis for any subsequent administrative regulations
and legal action.
The laboratory, or the organization of which it is part,
should be an entity that is legally authorized to function and
can be held legally responsible.
To ensure patient safety, the role of the national
pharmaceutical quality control laboratory should be defined
in the general pharmaceutical legislation of the country in
such a way that the results provided by it can, if necessary,
lead to enforcement of the law and legal action.
National pharmaceutical quality control
laboratories usually encompass essentially
two types of activity:
1- Compliance testing of active ingredient, pharmaceutical
excipients and pharmaceutical products.
2- Investigative testing of suspicious, illegal, counterfeit
substances or products, submitted for examination by
medicine inspectors, customs or police.
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Quality control laboratories of a manufacturer:Each company or factory of pharmaceutical
products must establish a quality control laboratory for self
inspection and monitoring each product batch before
marketing .
Marketing authorization (product license,
registration certificate):
A legal document issued by the competent medicines
regulatory authority that authorizes the marketing or
distribution of a new pharmaceutical product in the
respective country after evaluation for safety, efficacy and
quality. In terms of quality it establishes the detailed
composition of the pharmaceutical product and the quality
requirements for the product and its ingredients. It also
includes details of packaging, labeling, storage conditions,
shelf-life and approved conditions of use.
Quality control report
Quality control report is the report presented by the responsible
authorities quality control unit at the pharmaceutical product
factory or by the quality control laboratory of the ministry of
health.Quality control report is considered the passport for any
pharmaceutical product to be delivered to the market. Quality
control report is written by the responsible pharmacist.
The typical structure of the quality control report
QC report must contain the following parts:1-The title of the quality control laboratory :
a-In case of pharmaceutical product factory :
the name of the factory , the name of the unite of drug
analysis , the name of the department
b-In case of the quality control laboratory of the ministry
of health: the name of ministry of health, the name of the
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unite of drug analysis, the name of the department
2-The address of the quality control laboratory ,
telephone number(s),fax number,......
3-The report number. 4-The date of the report.
5-Analytical test report:-(SAMPLE INFORMATION)
A-PHYSICAL/VISUAL INSPECTION TEST
1- Labeling requirements:-Brand Name of the drug sample.
-Generic name of active ingredient(s).
-Dosage form and strength.
-Name of reference standard used (as claimed on label
e.g. USP, BP, IP, EP).
-Manufacturer’s Batch or Lot Number.
- Name of manufacturer and address (with
telephone and fax numbers).
-Manufacturing date.
-Expiry date.
-Storage conditions.
- Registration or licensed number.
2- Sampling requirements:-Name and address (with telephone and fax number, of
location/place where sample was collected.
-Date when the Lab receives sample.
-Name of test requester or sender of the
sample/date/sign.
3- Packaging:-Material (blister pack/card, bottle, others specify).
-Unit dose per blister card or container stated.
-Any print on the packing foil (if packed in blister
pack or card).
4-Description of dosage form:4
-Shape (circular, oval, flat sides , liquid , suspension,
other)
-Uniformity of shape.
-Uniformity of color
-No physical damage (cracks, breaks, erosion,
abrasion, sticky).
-Other observations (no foreign contaminant,
dirty marks, proper seal - for capsule).
B-DISINTEGRATION TEST (IF TESTED)
Did the drug pass observed disintegration test?
Time of complete disintegration----------- -----C-DISSOLUTION TEST (IF TESTED, SPECIFY METHOD
OR PROCEDURE AND ACCPETANCE CRITERIA:
………………………………………………………………………………………
Result: --------------------------------------------------------------------�
Passed
Failed
D-HARDNESS TEST (IF TESTED)
Result:
--------------------------------------------------------------------
E- OTHER TEST USED FOR VERIFICATION
AND IDENTIFICATION OF CONTENT OF
ACTIVE INGREDIENT
Specify the test method(s) and reference to a pharmacopeial
monograph
------------------------------------------------------------------------------------------------------Name of PAI(s):1-…………………………………
2-…………………………………..
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Identification results:
Present--------------------------Not present---------------------
Assay for content
Name of PAI (S)
1.......................................................
2........................................................
Acceptance criteria....................................................
………………………………………………………………….
Results----------------------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------
F-FINAL COMMENTS
The sample meets standards
The sample does not meet standards
(Reason:………………………………………………..…… …….)
The sample is doubtful for its quality testing
(Reason:……………………………….……..…………..……..)
and further testing is needed at a reference lab)
REPORT PREPARED BY:
Date: …………………………………....
Name:…………………………………….
Signature: ………………………………
REPORT REVIEWED BY:
Date : ………………………………….
Name: ……………………………………
Signature :…………..……………………
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B-ACTION TO BE TAKEN BY THE QC LAB*
1. Report to responsible authorities:
Report is writing to e.g. MOH Drug Regulatory
Authority :
Date and sign………………………… ……………………………………
2.Bureau of Drug and Narcotics Lab.
3. National Institute for Drug Quality Control.
Send to:
- USP Lab
- Send samples to the Reference Lab for confirmatory
testing.
( They should always be accompanied by a Request Form)
Date:………………………………………………….
Signature:…………………………………………….
* Action to be taken and communication between key
agencies in the country should be dependent on individual
country setting.
Exercise:-From your home ,bring a package of any pharmaceutical
product.
-Make a quality control report for this sample.
-Work individually.
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