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Objectives
Acquire
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Authorities
Europe: EC Directives
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History
1930s- Sulfanilimide
1960s- Thalidomide
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requirement
Satisfied Maintain
Company
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Drugs
HPFB
DIN Label
Claim
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Production Goals
Safety
Product is free of unwanted side effects when used appropriately by patient Product exactly matches the labelling and related documents Product has correct concentration, potency or therapeutic activity of active ingredient Product is free from contamination Product meets all standards, expectations; performs as claimed Product made consistently
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Identity
Strength
Purity
Quality
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GMP Categories
Sale Premises Equipment Personnel Sanitation Raw Material Testing Manufacturing Control
Quality Control Department Packaging Material Testing Finished Product Testing Records Samples Stability Sterile Products Medical Gases
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Sale C.02.003
No
distributor and no importer shall sell a drug unless it has been fabricated, packaged/labeled, tested, and stored in accordance with the requirements of this Division
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Personnel
C.02.006
education, training and
Appropriate
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Sanitation
C.02.007 - .008
Sanitation
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Sanitation
Hygiene
C.02.008
Health and eye examinations Report adverse health conditions Clothing requirements No direct skin contact with product Wash hands No jewelry or excessive makeup No smoking, eating, drinking, chewing, or keeping of plants in operations areas
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confirm the identity of the raw materials provide assurance that quality of the drug in dosage form will not be altered by raw material defects assure that raw materials have the characteristics that will provide the desired quantity or yield in manufacturing process
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of incoming materials are collected and tested before use Approved test methods and specifications are used Results must conform to specifications for release for use or sale Transportation and storage records
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Critical
processes are validated 2nd person verification of activities Quarantine system Labelling requirements
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Manufacturing Control
(contd)
Design Qualification (DQ) Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ)
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Control Responsibilities
Testing of bulk components prior to use by production Testing of finished product prior to release for sale Stability program (in association with QA)
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Assurance Responsibilities
Ensure GMP compliance Review batch records, labels Release product, based on QC test results Authorize all master documents and SOPs Training, auditing Customer complaints Recall
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CHANGE CONTROL
written procedure that describes the action to be taken if a change is proposed to facilities, etc. used in fabrication, packaging, and testing of drugs or any change that may affect quality or support system operation Planned or unplanned temporary departure from an approved process, specification or procedure with the potential to impact product quality
DEVIATION
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Records
C.02.020 - C.02.024
Document
all GMP activities Use Good Documentation Practices (GDP) Records must be readily available Needed to prove activities were done
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must be:
permanent (black or blue ink) legible, clear, concise accurate timely consistent complete
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Retain samples of each lot of raw material and finished product for specified period of time
Stability
Establish the length of time in which the product meets all specifications Monitor the drug for this period of time
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Products
Packaged in separate enclosed area by trained personnel using method to ensure sterility
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Summary
Pharmaceutical
Industry is regulated by
GMPs Good Manufacturing Practices must be followed GMPs ensure drug products are safe, pure and effective.
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