Journal of Drug Discovery and Therapeutics 1 (9) 2013, 13-19
Journal of Drug Discovery and Therapeutics 1 (9) 2013, 13-19
Journal of Drug Discovery and Therapeutics 1 (9) 2013, 13-19
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Abhijeet Welankiwar et al. / Journal of Drug Discovery and Therapeutics 1 (9) 2013, 13-19
Table 1: Categorization of Documents.
Second Category.
Standard Operating Procedures.
Lists.
Charts/Formats.
Test methods.
Reports.
Specifications.
MPCR and BPCR.
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First Category.
Documents for personal training.
Documents for Quality control
Documents for Building/Factory.
Documents for Materials/Stores
Documents for Engineering.
Documents for Distribution.
Documents for Market complaints.
Abhijeet Welankiwar et al. / Journal of Drug Discovery and Therapeutics 1 (9) 2013, 13-19
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Abhijeet Welankiwar et al. / Journal of Drug Discovery and Therapeutics 1 (9) 2013, 13-19
4. Initials of operator and different significant steps.
5. Check is made for identity and conformity with
packaging instructions.
6. Details of packaging operations carried out.
7. Details of sampling.
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Abhijeet Welankiwar et al. / Journal of Drug Discovery and Therapeutics 1 (9) 2013, 13-19
LEVEL
SUBJECT
SOP NO
Page No. of
Prepared by
Checked by
Approved by
Authorized by
Position
Signature
Date
Distribution Records:
Records of distribution shall be maintained in such way
that finished batch of a drug can be traced to retail level.
And It should also allow the prompt and complete recall
of batch whenever necessary.
Complaints and Adverse reaction records:
All complaints concerning the product quality has to
carefully reviewed and recorded as per standard
procedures. The complaints shall be evaluated by
designated personnel of company and records of action
which are taken shall be maintained.
Records concerning the adverse reactions result from the
use of drug shall be forwarded to licensing authority.
Specifications to be include in Documents:
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Abhijeet Welankiwar et al. / Journal of Drug Discovery and Therapeutics 1 (9) 2013, 13-19
Quality control Documentation:
As per GMP some important documents should readily
available to Q.C. department of company they are as
follows;
1. Specifications for R.M, P.M, intermediate and
finished product.
2. Sampling procedures for above.
3. Testing procedure and records.
4. Analytical reports and certificates.
5. Data from environmental monitoring.
6. Validation records of test methods.
7. Procedures for calibration of instruments and
maintenance of equipments.
8. All Q.C. documentation related to batch record.
9. Trend evaluation data should be maintained for
yields, environmental controls, and analytical test results.
10. Complete record should be maintained for any
modification in established method of testing.
11. Complete record should be maintained for periodic
calibration of lab instruments, apparatus, gauges and
recording devices.
12. Complete record should be maintained for stability
testing performed.
13. Complete record should be maintained for testing of
lab. Standards, reagents, standard solutions.
CONCLUSION:
REFERENCES:
1. Potdar M.A. Pharmaceutical Quality Assurance.2nd
edition; Nirali Prakashan: Pune.2010. Pg.no 7.1-7.36.
2. Aulton.M.E. Pharmaceutics.3rd edition; Churchill
Livingstone Elsevier. 2007. Pg no 254-257.
3. Lachman L., Lieberman, H. A., Joseph L. K. The Theory
and Practice of Industrial Pharmacy.3rd edition;
Varghese Publishing House; Mumbai.1990; Pg no
.810-815.
4. Kuchekar B.S, Pharmaceutical Jurisprudence.19th
edition; Nirali prakashan: Pune 2009:Pg no.5.1-5.67.
5. Sharma P.P, How to practice GMPs. 5th edition;
Vandana publication Pvt. Ltd: Delhi 2010:Pg no. 169234.
6. U.S. Food and Drug Administration. Guidance for
industry Quality system approach to pharmaceutical
CGmp regulation. Rockville, MD 20857; September,
2007.
7. WHO Technical Report Series, No. 908, 2003. Good
manufacturing Practices for Pharmaceuticals. Pg.no
70-72.
8. ICH Guideline, Good Manufacturing Practice Guide
For Active Pharmaceutical Ingredients Q7, Dated 10
November 2000.
9. Willing Sidney H, Stoker James R. Good
Manufacturing Practices for Pharmaceutical. 4th
edition. New York: Marcel Dekker, inc; 2004. Pg no.
282-285.
10. Schedule M. Good manufacturing practices and
requirements of Premises plant and equipment for
pharmaceutical products. Drug and Cosmetic Rules
1945.
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