cGMP.

cGMP

Schedule-M

Krupanidhi College of Pharmacy (Q.A)

Gaurav Kumar
M.Pharm (Q.A)
Date:

INTRODUCTION
1) Definition.
2) Timeline of GMP.
3) Components of CGMP.
4) Areas to be covered.
5) Conclusion.


DEFINITION:
 cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug
Administration (FDA).
 cGMP provide for systems that assure proper design, monitoring, and control of manufacturing processes and
facilities.
 Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring
that manufacturers of medications adequately control manufacturing operations.
 This includes establishing strong quality management systems, obtaining appropriate quality raw
materials, establishing robust operating procedures, detecting and investigating product quality deviations, and
maintaining reliable testing laboratories.
 This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent
instances of contamination, mix-ups, deviations, failures, and errors.
 This assures that drug products meet their quality standards.
Definition of GMP as per WHO: GMP is that part of quality assurance, which ensures that products are consistently
produced and controlled to the quality standards appropriate to their intended use and as required by the marketing
authorization.


TRAGEDIES PREECEDING CGMP REGULATIONS
1902 - Development of the Biologic Control Act
1906 - Development of the Pure Food and Drug Act
1938 - Federal Food, Drug and Cosmetic Act
1941 - Initiation of GMP
1944 - Development of Public Health Services Act

1962 - Kefauver-Harris Drug Amendments released (It introduced a requirement for drug manufacturers to provide proof of the
effectiveness and safety of their drugs before approval, required drug advertising to disclose accurate information about side
effects, and stopped cheap generic drugs being marketed as expensive drugs under new trade names as new "breakthrough"
medications)
1963 - Establishment of GMPs for Drugs

1975 - cGMP for Blood and Components Final Rule
1976 - Medical Device Amendments
1978 - cGMP for Drugs and Medical Devices

1979 - GLPs Final Rule
1980 - Infant Formula Act is passed
Sulfathiazole tablets contaminated with phenobarbital
1941 - 300 people died/injured
FDA to enforce and revise manufacturing and quality control requirements
1941 - GMP is born

Thalidomide tragedy
Thousands of children born with birth defects due to adverse drug reactions of morning sickness pill taken by mothers
Strengthen FDA’s regulations regarding experimentation on humans and proposed new way how drugs are approved
and regulated
“Proof of efficacy” law


COMPONENTS OF cGMP
a) GMP is a part of Q.A

b) GMP’s main function is to produce quality products consistently.
c) GMP must meet legal requirements of country.
d) GMP must meet both production and Q.C. related issues.

e) WHO further comments that the main function of GMP is to avoid mix-ups and contamination risks.


cGMP COVERS
a) General considerations
b) Personnel
c) Premises

d) Equipment
e) Sanitation
f)

SOP’s

g) Raw Materials

h) Self Inspection And Audit
i)

Master Formula Records

j)

Batch Manufacturing Records

k) Warehousing Area
l)

Labels And Other Printed Materials

m) QA

GENERAL CONSIDERATIONS
a) Compliance with GMP

b) Consistent uniform batches
c) Location And surroundings
d) Water system

e) Disposal Of Waste


PERSONNEL


Qualified Personnel
a)Experienced
b)Sufficient Number



Written job description



Trained



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




Gowning

PREMISES


Wyeth Pharmaceuticals, Goa


POINTS TO BE CONSIDERED.
1) Location

2) Design
3) Construction
 Location
Geography, climate and economic factors
Neighbours
a) What do they do?
Premises must be located to minimize risks of cross-contamination,
e.g. not located next to a malting factory with high airborne levels of yeast

Pollution/effluent control (E.T.P: Effluent treatment Plant).

 Design
a)
b)
c)
d)
e)
f)
g)
h)

Minimize risks of errors
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.
Maximum protection against entry of insects, birds and animals.
Finishing floors, walls, and Ceilings sshould be smooth, impervious, hard-wearing, easy to clean

 Specific Areas
1) Production areas
2) Quality control areas
3) Weighing areas
4) Storage areas
5) Ancillary areas
 Hygiene
Eating, Drinking, Smoking Should not be allowed in the Production area.

1. Design and construction features:
 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.
2. Lighting: Adequate lighting shall be provided in all areas
3. Ventilation, air filtration, air heating and cooling.
 Equipment for adequate control over air pressure, micro-organisms, dust, humidity, and temperature shall be provided when
appropriate for the manufacture, processing, packing, or holding of a drug product.
 Air filtration systems, including prefilters and particulate matter air filters, shall be used when appropriate on air
supplies to production areas. there shall be adequate exhaust systems or other systems adequate to control contaminants.
4. Plumbing
 Potable water shall be supplied under continuous positive pressure in a plumbing system. Potable water shall meet the
standards prescribed in the Environmental Protection Agency's Primary Drinking Water Regulations
 Drains shall be of adequate size and, where connected directly to a sewer, shall be provided with an air break to prevent
back siphonage.
5. 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
manner.


6. Washing and toilet facilities.
 Adequate washing facilities shall be provided, including hot and cold water, soap or detergent, air driers or single-service

towels, and clean toilet facilities easily accessible to working areas.
7. Sanitation.
 Building shall be free of infestation by rodents, birds, insects, and other vermin. Trash and organic waste matter shall be held
and disposed of in a timely and sanitary manner.

 There shall be written procedures for use of suitable rodenticides, insecticides, fungicides, fumigating agents, and cleaning
and sanitizing agents.
8. Maintenance.
 Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a good state
of repair.


Pfizer Facility, Grange Castle site in Clondalkin, Ireland.


EQUIPMENTS


Equipment shall be located, designed, constructed, adapted and maintained to suit the operation to be carried out.
Should be made of non reactive material, such as High grade of steel(316,302)
Equipment should bea) Calibrated.

b) Checked.
c) Labelled.
d) Sterilized.

e) Accompanied with SOP.


SANITATION


Written procedures for:
a) Gowning and de-gowning S.O.P.
b) hygiene, health
c) waste disposal
Implementation and training of the employees in basic sanitation and toilet habits.
Practices not permitted
a)eating, smoking
b) unhygienic practices


STANDARD OPERATING PROCEDURE
There shall be written Standard Operating Procedure for each operation
It includea)For Equipment.

b)For sampling.
c)For Testing.
d)For Process.

f)For Packaging.


RAW MATERIALS
An Inventory should be maintained for Raw materials to be used at any stage of manufacturing:
 Records should be maintain as per Schedule U.
 Should be purchased from approved sources.
 Must be checked by QC department on receipt .
 Should be labeled.


SELF AUDIT & INSPECTION
Regular independent inspection is necessary to evaluate the manufacturer’s compliance with GMP in all aspects of
manufacturing
Procedure for self inspection shall be documented indicating
a)Evaluation

b)Conclusion
c)Recommendations for Corrective action
There should be a BMR ( Batch Manufacturing Record) and MFR (Master Formula Record).


PACKAGING & LABELING CONTROL
1. Materials examination and usage criteria.
 Records shall be maintained for each different labeling and packaging material indicating receipt, examination or testing,
and whether accepted or rejected.
 Labels and other labeling materials for each different drug product, strength, dosage form, or quantity of contents shall be
stored separately with suitable identification.
 Use of visual inspection to conduct a 100-percent examination for correct labeling during or after completion of finishing
operations.
2. Labeling issuance.
 Strict control shall be exercised over labeling issued for use in drug product labeling operations.
 Labeling materials issued for a batch shall be carefully examined for identity and conformity to the labeling specified in the
master or batch production records.
3. Packaging and labeling operations.
 Prevention of mix-ups and cross-contamination by physical or spatial separation from operations on other drug products
 Examination of packaging and labeling materials for suitability and correctness before packaging operations, and
documentation of such examination in the batch production record.


4. Tamper-evident packaging requirements

 An OTC drug product for retail sale, that is not packaged in a tamper-resistant package or that is not properly labeled under
this section is adulterated under section 501 of the act or misbranded under section 502 of the act, or both.
 Package the product in a tamper-evident package, visible evidence to consumers that tampering has occurred.
5. Drug product inspection.
 Packaged and labeled products shall be examined during finishing operations to provide assurance that containers and
packages in the lot have the correct label.
 A representative sample of units shall be collected at the completion of finishing operations and shall be visually examined for
correct labeling.
 Results of these examinations shall be recorded in the batch production or control records.
6. Expiration dating.
 To assure that a drug product meets applicable standards of identity, strength, quality, and purity at the time of use, it shall
bear an expiration date determined by appropriate stability testing.
 If the drug product is to be reconstituted at the time of dispensing, its labeling shall bear expiration information for both the
reconstituted and un-reconstituted drug products.
 Expiration dates shall appear on labeling in accordance with the requirements.

WAREHOUSING AREA (WAREHOUSE)


 Warehousing area should be designed and adapted to ensure good 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.
 Fire Prevention


GMP IS ACTUALLY GOOD COMMON SENSE

Quality Management

Quality Assurance

GMP

Production and Quality Control


QUALITY ASSURANCE

The main objective of the quality assurance is to ensure the products are of the quality required for their intended use
Functions Adequates are made for manufacturing, supply and the use of correct starting and packing material.

 Adequate control on starting material, intermediate, and bulk products.
 Process validation in accordance with established procedures.


CONCLUSION
 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.
 The role and involvement of senior management is crucial


.THANK YOU.


cGMP.

Recommandé

Recommandé

Contenu connexe

Tendances

Tendances (20)

En vedette

En vedette (10)

Similaire à cGMP.

Similaire à cGMP. (20)

Dernier

Dernier (20)

cGMP.