PowerPoint Presentation

cGMP’s and QA for Pharmaceutical Manufacturing. Tapamoy Chakraborty.

Quality Choices Engine size Make and model Right strength ....

cGMP Buildings and Facilities SOPs Warehouse Facilities Sampling & Dispensing Manufacturing Areas IPQC areas Records and Reports Process Controls Cleaning Process Validation Reworks Ingredients controls Training Investigations Lab Controls Utilities Stability Programs.

GLP. Internal Quality System Audits. General Requirements.

What are the Benefits of cGMPs?. They outline a Quality System that reduces or prevents errors Ensures products are safe for use in humans Prevent/control contamination and cross- contamination Minimizes variations in potency of the drug Ensures physiological activity Prevent side effects and toxicity due to variations in drug content and potency Prevents mislabeling and adulteration.

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Good Manufacturing Practices. 1. Quality Assurance 2 . Sanitation and hygiene 3 . Qualification and validation 4 . Product recalls 5 . Contract production and analysis.

Good Manufacturing Practices. 6 .Self inspection and quality audits Items for self-inspection Self-inspection team Frequency of self-inspection Self-inspection report Follow-up action Quality audit Suppliers’ audits and approval 7 . Training.

Good Manufacturing Practices. 8 . Building and Facilities General Ancillary areas Storage areas Weighing areas Production areas Quality control area 9 . Equipment.

Good Manufacturing Practices. 10. Materials Starting materials Packaging materials Intermediate and bulk products Finished products Rejected, recovered, reprocessed and reworked materials Recalled products Returned goods Reagents and culture media Reference standards Waste materials Miscellaneous.

Good Manufacturing Practices. 11. Documentation or Records Documents required: Labels Testing procedures Specifications for starting and packaging materials, for intermediate and bulk products and for finished products Master formulae and Batch Processing Records Packaging instructions and Batch Packaging Records Standard Operating procedures (SOP's) and records Logbooks.

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QUALITY IS A DEPENDED VARIABLE. Materials Measurements Manpower QUALITY Methods Machines Environment.

THE 3 STEPS FOR QUALITY AND THE PDSA CYCLE. PLAN.

FACTORS IN DRUG QUALITY ASSURANCE. DRUG PRODUCT QUALITY.

Quality Assurance: Essential At All Stages.

Target Quality Profiling- A Perspective. Customer.

© ICH, November 2010. Nov 2005 & Nov 2008. November 2005.

© ICH, November 2010. Q8(R2) - Example QbD Approach.

Process Development. Control Strategy Development.

© ICH, November 2010. Pharmaceutical Quality System - Q10.

© ICH, November 2010. ICH Q8, Q9 and Q10 Working Together.

DRUG DISCOVERY & DEVELOPMENT: REGULATORY REQUIRMENTS.

HYGIENE AND SANITATION. WHY IS HYGIENE AND SANITATION IMPORTANT?.

PEOPLE. CONTAMINATION. IMPURE. UNCLEAN. devil4. UNFIT FOR USE.

*Wash hands with soap and water. HYGIENE AND SANITATION PRACTICES.

GMP Quality Standards practice theory Quality Product.

EQUIPMENT MUST BE LOCATED FOR EASY MAINTENANCE!. Green stuck Click image to download.

WHEN ?. . Time flies Click image to download. WHAT ?.

EQUIPMENT MAINTENANCE. MECHANICAL AND PRECISION EQUIPMENT MUST BE CHECKED REGULARLY . ALL AUTOMATIC AND ELECTRONIC EQUIPMENT LIKE COMPUTERS MUST ALSO BE TESTED AND INSPECTED ..

ALL MATERIAL RECEIPT MUST BE. IN GOOD CONDITION CLEAN AND IDENTIFIED Intact, no damage.

All components must be stored in a safe and orderly way . . ..

Apple barrell - Click image to download.. Reserve samples for every approved component….. Clearly identified Kept for at least one year after the expiration of the Product A rejected component must be properly identified and kept separate until it is disposed of..

FOLLOWING SOP’S IS VITAL. …….AND SO ARE THE RECORDS WE KEEP!.

Padlock 2 - Click image to download.. No one changes the SOP’s… Manufacturing and Control Monographs ...until it has been approved by the heads of Manufacturing and Quality Control.

AVOID/MINIMIZE MIX-UPS AND ERRORS. ENSURE CONSISTENT QUALITY.

PREPARATION FOR PACKAGING & LABELLING. Mad scientist 3 - Click image to download..

The packaging. department. follows the. packaging directions.

ALL CONTAINERS MUST PROVIDE PROTECTION FROM EXTERNAL CONTAMINATION.

ACCURATE RECORD KEEPING IS VITAL …….. RECORDS MUST BE FILLED OUT AT THE TIME WE COMPLETE THE JOB!!!.

DON’T TRUST YOUR MEMORY!!. RECORDS MUST BE FILLED OUT AT THE TIME WE COMPLETE THE JOB!.

Records and Reports. Quality Records are the proof that the procedures were followed and they show traceability of product. Examples: Lot History Records Laboratory Notebooks Protocols Reports Logbooks Distribution Records Complaint Files.

BATCH PRODUCTION RECORDS MUST BE CAREFULLY FOLLOWED AND MONITORED…...

Summary and conclusions:. GMP compliance is not an option Quality should be built into the product GMP's are very similar and are really Good Common Sense Good Practices cover all aspects of manufacturing activities prior to supply.

Quality Standards GMP is everyone's responsibility.

SHARED RESPONSIBILITY OF. GMP………….…. ESTABLISHMENT AND EMPLOYEES.

Drug Regulatory System in India. Drug is in concurrent list of Indian Constitution. It is governed by both Centre and State Governments under the Drugs & Cosmetics Act, 1940 and Rules 1945 thereunder . The principle on which the Drugs & Cosmetics Act function is by a system of licensing under which all the activities involved in manufacture, sale and distribution of Drugs & Cosmetics are controlled ..

Pharmacists in the Pharmaceutical Industry. AREA OF PHARMA INDUSTRY HANDS ON/SUPERVIOSORY ROLE RESEARCH & DEVELOPMENT Drug discover, reserve engineering , formulation and process development, up scaling from pilot to manufacturing, trouble shooting, stability, packaging development PRODUCTION/MANUFACTURING Production /manufacturing of bulk drugs & intermediate finished medicines, vaccines & other biological products, veterinary medicines, ayurvedic medicines, diagnostic products & medical devices. PACKAGING Various stages of packaging of pharmaceuticals QUALITY CONTROL Testing throughout the life cycle of the drug and finished product. QUALITY ASSURANCE Preparing, reviewing & submitting documents, conducting trainings, internal audits, assuring total quality management. SALES & MARKETING Strategic planning, team management and marketing of pharmaceuticals. Working as medical representative. REGULATORY AFFAIRS Preparing, reviewing, communicating, submitting registration documents on pharmaceuticals to regulatory agencies to get R&D testing, production & marketing approvals, issues related to patents.

Some Regulatory Authorities and Agencies Worldwide.

- Pandit Jawaharlal Nehru In Discovery Of India. “ Nothing can be clearer than the fact that India has resources as well as the intelligence, skill and capacity to advance rapidly. She has the accumulated cultural and spiritual experience of ages behind her. She can progress both in scientific theory and the application of science and become a great industrial nation ”.