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CURRRENT GOOD MANUFACTURING

PRACTISE (cGMP)

By 1Jemal B.
OUT LINE OF THE CHAPTER

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 Introduction

 Building and facilities

 Organization and personnel

 Material, packaging, labeling control

 Production & process controls

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 Conclusion
 OBJECTIVE

 After learning this chapter students are expected to discuss

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 What GMP is

 Principles of cGMP

 Why GMP

 Quality control

 Quality assurance
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 INTRODUCTION

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 What is GMP ?
 GMP is that part of Quality assurance which ensures that the
products are consistently manufactured and controlled to the
Quality standards appropriate to their intended use
 "GMP" - A set of principles and procedures which, when
followed by manufacturers for therapeutic goods, helps ensure
that the products manufactured will have the
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required quality.
 INTRODUCTION..

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 Usually “cGMP” – where c =current, to emphasize that the

expectations are dynamic

 Quality of a medicinal product is measured by it’s fitness for

purpose .

 Safety and efficacy are not separable from Quality but part of it

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 INTRODUCTION….
 CURRENT GMP

 cGMP regulations are established by FDA

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 It contains minimum requirements for the methods, facilities and controls
used in manufacturing of a drug product & packing .
 The regulations make sure that a product is safe for use, and that it has the
ingredients and strength it claims to have.
 The approval process for new drug and generic drug marketing applications
includes a review of the manufacturer's compliance with the cGMP
 FDA can issue a warning letter or initiate other regulatory

actions against a company that fails to comply with the regulations

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 INTRODUCTION….

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 A basic tenet of GMP is that quality cannot be tested into a batch of
product but must be built into each batch of product during all
stages of the manufacturing process

 It is designed to minimize the risks involved in any pharmaceutical

production that cannot be eliminated through testing the final
product
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 INTRODUCTION….

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 Some of the main risks are

 unexpected contamination of products, causing damage to health

or even death

 incorrect labels on containers, which could mean that patients

receive the wrong medicine

 insufficient or too much active ingredient, resulting in ineffective

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treatment or adverse effects

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 Why GMP is important?

 A poor quality medicine may contain toxic substances that have

been unintentionally added.

 A medicine that contains little or none of the claimed ingredient

will not have the intended therapeutic effect

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 INTRODUCTION…..
 GMP boost pharmaceutical export opportunities

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 Most countries will only accept import and sale of medicines that
have been manufactured to internationally

recognized GMP.
 Governments seeking to promote their countries export of
pharmaceuticals can do so by making GMP mandatory for all
pharmaceutical production and by training their inspectors in GMP
requirements.
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 INTRODUCTION….
 GMP Covers…

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 ALL aspects of production; from the starting materials, premises
and equipment to the training and personal hygiene of staff.
 Detailed, written procedures are essential for each process that
could affect the quality of the finished product.
 There must be systems to provide documented proof that correct
procedures are consistently followed at each step in the
manufacturing process - every time a product is made
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 INTRODUCTION…

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 The Quality of a formulation or a bulk drug depends on the

Quality of those producing it.

 GMP is the magic key that opens the door of the Quality

 In matter of GMP, swim with the current and in matter of Quality

stand like a rock!

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 QA,GMP & QC INTER-RELATIONSHIP

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 QUALITY ASSURANCE (QA)
 It is the sum total of the organized arrangements with the
objective of ensuring that products will be of the required quality
for their intended use
 GMP
 Is that part of Quality Assurance aimed at ensuring that products
are consistently manufactured to a quality appropriate to their
intended use 16
 QA, GMP & QC INTER-RELATIONSHIP

 QUALITY CONTROL (QC)

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 Is that part of GMP concerned with sampling, specification

testing, documentation & release procedures which ensure that the

necessary & relevant tests are performed

 The product is released for use only after ascertaining

it’s quality
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QC & QA
QC & QA…..

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 PRINCIPLES OF CGMP
a) General considerations
b) Personnel

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c) Premises
d) Equipment
e) Sanitation
f) SOP’s
g) Raw Materials
h) Self Inspection And Audit
k) Warehousing Area 21

l) Labels And Other Printed Materials

 GENERAL CONSIDERATIONS

 Compliance with GMP

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 Consistent uniform batches

 Location And surroundings

 Water system

 Disposal Of Waste

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 PERSONNEL

Qualified Personnel

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a)Experienced
b)Sufficient Number

Written job description

Trained
 Health
a) Diseases.(communicable or non
b) Open Lesions.
C) Skin diseases.
d) Allergic conditions

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PREMISES

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 PREMISES……. POINTS TO BE CONSIDERED

 Location

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 Design

 Construction

 Location
 Geography, climate and economic factor
 What do they do?
 Premises must be located to minimize risks of cross-contamination
 Not located next to a malting factory with high airborne levels of
yeast 26

 Pollution/effluent control
 PREMISES….
 Design
 Minimize risks of errors

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 Permit effective cleaning
 Permit effective maintenance
 Avoid cross-contamination, build-up of dirt and dust
 Maximum protection against entry of insects, birds and animals
 Separate facilities for other products such as some antibiotics, hormones,
cytotoxic substances.
 Finishing floors, walls, and Ceilings should be smooth, impervious,
hard-wearing, easy to clean 27
 PREMISES..
 Specific Areas

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 Production areas
 Quality control areas
 Weighing areas
 Storage areas
 Ancillary areas

 Hygiene
 Eating, Drinking, Smoking Should not be allowed in the
Production area
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 PREMISES….

 Design and construction features:

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 Any building used in the manufacture, processing, packing,
or holding of a drug product shall be of suitable size,
construction and location to facilitate cleaning, maintenance.
 The orderly placement of equipment and materials to prevent
mix-ups between different components, drug product
containers, closures, labeling, in-process materials, or drug
products, and to prevent contamination. 29

 Lighting: Adequate lighting shall be provided in all areas

 PREMISES..
 Ventilation, air filtration, air heating and cooling

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 Plumbing
 Potable water shall be supplied under continuous positive pressure
in a plumbing system.
 Drains shall be of adequate size and, where connected directly to a
sewer
 Sewage and refuse
 Sewage, trash, and other refuse in and from the building and
immediate premises shall be disposed of in a safe and sanitary 30

manner
PREMISES…
 Washing and toilet facilities.

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 Adequate washing facilities shall be provided and clean toilet facilities easily
accessible to working areas
 Sanitation
 Building shall be free of infestation by rodents, birds, insects, and other vermin
 There shall be written procedures for use of suitable rodenticides, insecticides,
fungicides
 Maintenance

 Any building used in the manufacture, processing, packing, or holding of a

drug product shall be maintained in a good state
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of repair
 EQUIPMENTS
 Equipment shall be located, designed, constructed, and

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maintained to suit the operation to be carried out.
 Should be made of non reactive material, such as High grade of
steel
 Equipment should be
 Checked.

 Labelled.

 Sterilized.

 Accompanied with SOP 32

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 SANITATION

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Written procedures for:

a) Gowning and de-gowning S.O.P.

b) hygiene, health

c) waste disposal

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STANDARD OPERATING PROCEDURE

There shall be written Standard

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Operating Procedure for each operation
It include
For Equipment.
For sampling.
For Testing.
For Process.
For Packaging

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 RAW MATERIALS

 An Inventory should be maintained for Raw materials to be used

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at any stage of manufacturing

 Records should be maintain as per Schedule

 Should be purchased from approved sources.

 Must be checked by QC department on receipt .

 Should be labeled

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 SELF AUDIT & INSPECTION

 Regular independent inspection is necessary to evaluate the

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manufacturer’s compliance with GMP in all aspects of

manufacturing

 Procedure for self inspection shall be documented indicating

 Evaluation

 Conclusion

 Recommendations for Corrective action 38

 PACKAGING & LABELING CONTROL
 Labeling issuance.

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 Strict control shall be exercised over labeling issued for use in drug
product
 Labeling materials issued for a batch shall be carefully examined for
identity and conformity
 Packaging
 Prevention of mix-ups and cross-contamination
 Expiration dating

 To assure that a drug product meets applicable standards of identity,

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strength, quality, and purity at the time of use, it shall bear an expiration
date
WAREHOUSING AREA (WAREHOUSE

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 WAREHOUSING AREA (WAREHOUSE

 Warehousing area should be designed and adapted to ensure good

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storage conditions.
 Should be clean, dry and maintained with acceptable temperature
limits.
 Should have appropriate house-keeping and rodents, pests and vermin
control.
 Separate sampling area for active raw material and excipients.
 Every Material stored should be labeled properly.
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 Fire Prevention
 CONCLUSION

 Pharmaceutical Industry is regulated by GMPs

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 Good Manufacturing Practices must be followed

 GMPs ensure drug products are safe, pure and effective

 Quality should be built into the product

 The role and involvement of senior management is crucial

 The main function of GMP is to avoid mix-ups and contamination

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risks
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