Manufacturing Practice steps, Precautions, Clealiness, Sample viability, Quality Assurance

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Department of Biotechnology, SPMVV, Tirupati
De

2. What is GMP?
 Good Manufacturing
Practice is a set of
regulations, codes, and
guidelines for the
manufacture of drug
substances and drug
products, medical devices,
in vivo and in vitro
diagnostic products, and
foods.
GMP handbooks for everyindustry
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3. OBJECTIVE
high quality products to theGuarantee
consumer.
Delivering products free of all
possible contamination
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4. GENERAL REQUIREMENTS
Avoid risks and possibilities of mix-up at all
stages of Mfg, labeling Pkg and testing
AHUs, comfort of the personnel working
and regular monitoring of temp & humidity,
Particle Count, DOP testing etc.
Proper drainage system which prevents
Avoid open channels and if
must be able to clean and
backflow.
provided
disinfect.
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5. Building & Facilities
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1. Design and constructionfeatures.
2. Lighting.
3. Ventilation, air filtration, air heating andcooling.
4. Plumbing.
5. Sewage and refuse.
6. Washing and toiletfacilities.
7. Sanitation.
8. Maintenance.

6. Good Manufacturing Practices
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 A basic principleof GMP is that quality cannot be
tested into a batch of product but must be built
into each batch of product during all stagesof the
manufacturing process.
 It is designed to minimize the risks involved inany
pharmaceutical production that cannot be
eliminated through testing the final product.

7. Ten Principles of GMP
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1. Design and construct the facilitiesand equipments
properly
2. Follow written procedures and Instructions
3. Documentwork
4. Validate work
5. Monitor facilities andequipment
6. Write step by step operating procedures and workon
instructions
7. Design ,develop and demonstrate jobcompetence
8. Protect againstcontamination
9. Control components and product related processes
10. Conduct planned and periodicaudits

8. GMP Categories
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 Sale
 Premises
 Equipment
 Personnel
 Sanitation
 Raw Material Testing
 Manufacturing Control
 Packaging Material Testing
 Finished Product Testing
 Quality Control
Department
 Records
 Samples
 Stability
 Sterile Products

9. Sale
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 Nodistributor… and no importershall sell a drug unless
it has been fabricated, packaged/labeled, tested, and
stored .
Premises & Equipment
 Permits effectivecleaning
 Preventscontamination
 Orderlyconditions
 Good state of repair

13. Personnel
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 Appropriate education, training andexperience
 Sufficient number of people
 Receive GMP training
sanitation
 Sanitation Program to preventcontamination
 Limit the sources and types ofcontamination
 Cleaning procedures for facilities &equipment
 Pestcontrol
 Environmental monitoring

14. Raw Material, Packaging Material and
Finished Product Testing
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 each lotor batch of raw material is tested
 confirm the identity of the rawmaterials
 provide assurance that quality of the drug in dosage
 Samples of incoming materialsare
collected and tested before use
 Approved test methodsand specifications
are used
 Results mustconform tospecifications
forrelease for use orsale
 Transportation and storagerecords

16. Manufacturing Control
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 Written procedures are established andfollowed
 Master formulae, manufacturing order andpackaging
order
 Critical processes arevalidated
 2nd person verification ofactivities
 Self-Inspection Programmed

18. Quality Control Department
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 Quality Control Responsibilities
 Testing of bulk components prior to use byproduction
 Testing of finished product prior to release forsale
 Stability program
 Review batch records, labels
 Release product, based on QC testresults
 Training, auditing
 Customercomplaints

21. Records
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 Document all GMPactivities
 Use Good Documentation Practices (GDP)
 Records must be readilyavailable
Good Documentation Practices
 Documentation must be:
 permanent (black or blueink)
 legible, clear, concise
 accurate
 Timely, complete

22. Samples
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 Retain samplesof each lot of raw material and finished
product for specified period oftime
Stability
 Establish the length of time inwhich the
product meets allspecifications
 Monitor thedrug for this period of time
Sterile Products
 Packaged in separate enclosed area by trainedpersonnel
using method to ensuresterility

24. Why GMP is important
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 A poorquality medicine maycontain toxicsubstances
that have been unintentionallyadded.
 A medicine that contains little or none of the claimed
ingredient will not have the intended therapeuticeffect.

26. GMP IN……
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 GMP in solid dosage forms
 GMP in semisolid dosageforms
 GMP in Liquid orals
 GMP in Parenterals Production
 GMP in Ayurvedic medicines
 GMP in Bio technological products
 GMP in Nutraceuticals andcosmeceuticals
 GMP in Homeopathic medicines

27. Some of the main risks are….
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 unexpected contamination of products, causingdamage
to health or evendeath.
 incorrect labels on containers, which could meanthat
patients receive the wrong medicine.
 insufficientor too much active ingredient, resulting in
ineffective treatment oradverse effects.

28. Conclusion
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From theabovediscussionwecan conclude that -
 Pharmaceutical Industry is regulated byGMPs
 Good Manufacturing Practices must befollowed
 GMPs ensure drug products are safe, pure and
effective.

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