Introduction to GMP

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Objectives
Acquire

basic knowledge of Good Manufacturing Practices (GMP)

What are GMPs ? Why are they important ?

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History of Food and Drugs Act

Government

Authorities

Canada: Health Canada Health Products and Food Branch (HPFB)

USA: Food & Drug Administration (FDA)

Europe: EC Directives

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History

Food and Drugs Act Food and Drug Regulations

Division 2 : Good Manufacturing Practices First purity laws enacted

1900s- Adulterated Food

1930s- Sulfanilimide

Drugs had to be proven safe

1960s- Thalidomide

Drugs had to be proven safe and effective through clinical trials

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Why are GMPs important?

Government
Ensure Reduce

requirement

quality product rejects, recalls customers manufacturing consistency

Satisfied Maintain

Company

image and reputation

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Drugs
HPFB

Definition: Any substance or

mixture of substances manufactured, sold or represented for use in

a) the diagnosis, treatment, mitigation or prevention of a disease, a disorder, an abnormal physical state or the symptoms thereof in humans or animals b) restoring, correcting or modifying organic functions in humans or animals c) disinfection in premises in which food is manufactured, prepared or kept

DIN Label

Claim

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Food and Drugs Act

Establishment

license Site Reference File HPFB Inspections

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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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Premises C.02.004 Equipment C.02.005

Permits

effective cleaning Prevents contamination Orderly conditions Good state of repair

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Personnel

C.02.006
education, training and

Appropriate

experience Sufficient number of people Receive GMP training

Initial and continuing training as relevant to job responsibilities

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Sanitation

C.02.007 - .008

Sanitation

Program to prevent contamination

Limit the sources and types of contamination Cleaning procedures for facilities & equipment Pest control Environmental monitoring Documented evidence

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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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Raw Material Testing C.02.009 .010

each lot or batch of raw material is tested three objectives

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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Raw Material, Packaging Material and Finished Product Testing

Samples

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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Manufacturing Control C.02.011

Written

procedures are established and followed

Master formulae, manufacturing order and packaging order

Critical

processes are validated 2nd person verification of activities Quarantine system Labelling requirements

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Manufacturing Control C.02.012

Recall

Programme Self-Inspection Programme Ensure compliance with vendors/contractors

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Manufacturing Control

(contd)

Validation: the documented act of demonstrating

that any procedure, process, equipment, material, activity, or system will consistently lead to the expected results
TPP 1998 Edition

Design Qualification (DQ) Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ)

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Quality Control Department C.02.013 - C.02.015

Quality

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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Quality Control Department C.02.013 - C.02.015

Quality

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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Key Quality Terms

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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Good Documentation Practices

Documentation

must be:

permanent (black or blue ink) legible, clear, concise accurate timely consistent complete

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Samples and Stability

Samples

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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Sterile Products C.02.029

Sterile

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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