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Good Manufacturing Practices
Dr. Chander Aurora
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Regulatory Lifecycle of a Drug
Discovery Pre-Clinical Trials Animal Testing Investigational New Drug Application (IND) Permission to Test in Humans Clinical Trials Human Testing New Drug Application (NDA) Permission to Market Market Launch Dr. Arora - Good Manufacturing Practices
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Clinical Trials Phase Marketing Application Review Post-Marketing
1, 2 and 3 Marketing Application Review NDA – New Drug Application Post-Marketing Phase 4 Dr. Arora - Good Manufacturing Practices
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Manufacturing Manufacturing is Even more disciplined activity. . .
GMP takes priority QC becomes an important driver! Dr. Arora - Good Manufacturing Practices
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International Harmonization
cGMPs exist in all major markets Europe Japan US International Conference on Harmonization has aligned cGMPs between major markets Interpretation can still be issue Emphasis different from market to market Dr. Arora - Good Manufacturing Practices
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Objectives To understand where the regulations are coming from?
Who enforces them? Why do we need to comply? Dr. Arora - Good Manufacturing Practices
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Objectives continued Manufacturing Practices To understand the:
Fundamentals Benefits Key parts of GMP - Good Manufacturing Practices Dr. Arora - Good Manufacturing Practices
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Compliance Written into Federal Register – mandatory regulations
GLPs (Good Laboratory Practices) Pre-clinical, EPA GCPs (Good Clinical Practices) Clinical studies GMPs (Good Manufacturing Practices) Production and distribution of drugs and devices for human use Dr. Arora - Good Manufacturing Practices
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GMP for what? The acronym "GMP" (Good Manufacturing Practice) is used internationally to describe: A set of principles and procedures which, when followed by manufacturers of therapeutic goods Helps ensure that the products manufactured will have the required quality. Dr. Arora - Good Manufacturing Practices
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GMP – Why? Regulations & Guidelines GMP works in conjunction with
History & Current GMP works in conjunction with Quality Control, QC Quality Assurance, QA Dr. Arora - Good Manufacturing Practices
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GMP or cGMP Current - c Good Manufacturing Practices
Comes from Food Drug and Cosmetic Act Rules set up by FDA Food and Drug Administration Drug Manufacturers need to follow in order to ensure that a safe and effective product is manufactured for the consumers Dr. Arora - Good Manufacturing Practices
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GMPs Importance Government Requirement Ensures Quality Product
Reduces Rejects & Recalls Maintains Manufacturing Consistency Satisfied Customers Company Image & Reputation Dr. Arora - Good Manufacturing Practices
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Enforcement FDA (Food & Drug Administration) FDA is an Agency under
Interprets and Enforces the law FDA is an Agency under Department of Health & Human Services (DHHS) FDA has EIGHT branches Dr. Arora - Good Manufacturing Practices
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FDA Organization and Structure
Commissioner Office of External Affairs Office of AIDS and Special Health Issues Office of Consumer Affairs Office of Health Affairs Office of Legislative Affairs Office of Public Affairs Office of Women’s Health Office of Management and Systems Office of Information Resources and Management Office of Management Office of Planning and Evaluation Office of Operations Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Drug Evaluation and Research Center for Food Safety and Applied Nutrition Center for Veterinary Medicine National Center for Toxicological Research Office of Orphan Products Development Office of Regulatory Affairs Office of Policy Regulations Policy and Management Staff Policy Development and Coordination Staff Policy Research Staff International Policy Staff Dr. Arora - Good Manufacturing Practices
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GMP Regulations Current Good Manufacturing Practices for Pharmaceuticals (cGMP) Proposed by FDA February 13, 1976 Published in final form in CFR September 29, 1978 Effective March 28, 1979 Dr. Arora - Good Manufacturing Practices
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cGMP Requirements cGMP and the Act assures
The manufactured Drug meets and possess the characteristics for which it has been approved: Safety Identity Strength Quality Purity Dr. Arora - Good Manufacturing Practices
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Non-Compliance Consequences
BUSINESS LEGAL Expensive to do recalls Loss of sales Bad publicity Potential harm to: Patients Customers FDA 483 FDA Warning Letters Consent Decree Recall of Product Product Seizure Plant Injunction Company Closure Debarment Non-Compliance Consequences Dr. Arora - Good Manufacturing Practices
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Validation Definition
Documented evidence that provides a high degree of assurance that a specific process, facility, or support system will consistently produce a product meeting its predetermined specifications and quality attributes. Validation helps assure that: Products are pure, safe and effective Dr. Arora - Good Manufacturing Practices
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Benefits of cGMP cGMPs outlines a Quality System
Reduces / Prevents Errors Ensures that products are safe for humans use Prevents & Controls Contamination / Cross contamination Minimizes Potency variation of drugs Prevents side effects Ensures reproducible physiological activity Prevents mislabeling and adulteration Dr. Arora - Good Manufacturing Practices
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A. General Provisions Minimum requirements Applies to Drug products
Additional detail for biologically derives products Parts Additional detail for products derived from human cells or tissue Part 1271 Over-The-Counter(OTC) Drugs exempted Nutra-ceuticals were exempted* Under GMP from July 2010 Dr. Arora - Good Manufacturing Practices
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Standard Operating Procedures
Good SOPs contain the following: Purpose or scope Materials Procedure Must be written in proper order Must include sufficient detail for operator to follow Should include “checkers” for calculations Must include initials and signature of operator Must have Supervisors review and sign off Should be reviewed and updated as needed Dr. Arora - Good Manufacturing Practices
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Batch Records FDA Requirement cGMP requirement QSR requirement
ISO requirement Failing to do so can get you into a heap of trouble! Used to ensure consistent product Dr. Arora - Good Manufacturing Practices
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Batch Record: Record Keeping
Record keeping requirements Black ink No white out Single line, Date, Initial No blanks N/A any lines which do not apply Legible Dr. Arora - Good Manufacturing Practices
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Who is responsible for GMP?
Everyone Dr. Arora - Good Manufacturing Practices
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TRUST Manufacturer Doctor & Pharmacist Patient
Dr. Arora - Good Manufacturing Practices
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What does FDA do? Approve products Monitor drug performance
Safety Effectiveness Risk/Benefit determination Monitor drug performance Monitor investigational studies Inspect manufacturers Inform physicians and consumers Dr. Arora - Good Manufacturing Practices
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FDA and Blood Donations
Do they oversee Blood Donations? YES! What testing or procedures do they require? Donor screening: medical history Blood testing: for HIV, Hep, Syphilis, etc. SOPs for drawing, testing, processing, inventory control and lot traceability Dr. Arora - Good Manufacturing Practices
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“If it is not documented . . .
Bottom Line Document, Document, Document!!! In FDA-Language: “If it is not documented . . . It did not happen!” or “It’s a rumor!” Dr. Arora - Good Manufacturing Practices
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The Cardinal Rules of GMP
To err is human. To destroy the evidence is a felony Maintain every record as if it were going to be reviewed by the FDA. Your signature is precious Never sign, approve, or authorize anything you are not absolutely sure is correct. Dr. Arora - Good Manufacturing Practices
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