GMP presentation.pptx

Good Manufacturing Practice (GMP) is a system for ensuring that products are
consistently produced and controlled according to quality standards. It is designed to
minimize the risks involved in any pharmaceutical production that cannot be eliminated
through testing the final product.
GMP regulations were introduced in the form of amended Schedule M in 1988. The
Schedule M has again been amended in a major way by the Drugs and Cosmetics (8th
Amendment) Rules, 2001.
GMP covers 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.
GOOD MANUFACTURING PRACTICES
(Schedule M)

OBJECTIVES
1. To ensure that products are consistently manufactured and controlled to the
specified quality.
2. Concerned with all aspects of production and quality control
3. In the manufacture of cosmetics products, overall control and monitoring
4. To ensure that the consumer receives products of specified quality.
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.
WHY GMP IS IMPORTANT?

TEN PRINCIPLES OF GMP
1. Design and construct the facilities and equipments properly.
2. Follow written procedures and instructions
3. Documents work
4. Validate work
5. Monitor facilities and equipment
6. Write step by step operating procedures and work on instructions
7. Design, develop and demonstrate job competence
8. Protect against contamination
9. Control components and product related processes
10. Conduct planned and periodic audits

PART-I- GMP FOR PREMISES AND MATERIALS
PART-I(A)- SPECIFIC REQUIREMENTS FOR MANUFACTURE OF STERILE
PRODUCTS, SVPs & LVPs, AND STERILE OPTHALMIC PREPARATIONS

PART-I(B)- SPECIFIC REQUIREMENTS FOR MANUFACTURE OF ORAL
SOLID DOSAGE FORMS (TABLETS AND CAPSULES)
PART-I(E)- SPECIFIC REQUIREMENTS FOR MANUFACTURE OF
METERED DOSE INHALERS (MDI)
PART-I(D)- SPECIFIC REQUIREMENTS FOR MANUFACTURE OF
EXTERNAL PREPARATIONS (CREAMS, OINTMENT, PASTES, EMULSION,
LOTIONS, SOLUTIONS, DUSTING POWDERS AND DENTAL PRODUCTS)
PART-I(C)- SPECIFIC REQUIREMENTS FOR MANUFACTURE OF ORAL
LIQUIDS (SYRUPS, ELIXIRS, EMULSION AND SUSPENSIONS)
PART-I(F)- SPECIFIC REQUIREMENTS FOR PREMISES, PLANT AND
MATERIALS FOR MANUFACTUREOF BULK DRUGS
PART-II- SPECIFIC REQUIREMENTS OF PLANT AND EQUIPMENT

1. General Requirements
 Location and surroundings: The location of the factory and its surroundings should be
such as to avoid risk of contamination from external environment including open sewage,
drain, public lavatory or any factory which produces disagreeable or obnoxious odour,
fumes, excessive soot, dust, smoke, chemical or biological emissions.
Buildings and premises:
• Buildings must be designed with adequate size and space for operations (helps to
eliminate mix-ups).
• Facilities must be validated
• There must be a good flow pattern for personnel, materials, products and waste materials
(flow from clean to dirty)
• The facility must be easy to clean and sanitize (surfaces, equipment, exposed cords,
floors, ceilings…)
• Must have engineering documents describing the layout of the clean rooms – controlled
documents
• Changes to the layout of the room after it has been validated must go through change
control procedures and may require revalidation of the room
• Microorganisms, particulates, and hazardous materials must be controlled

 Water system: There shall be validated system for treatment of water so as to produce
Purified Water conforming to IP specification. Water shall be stored in tanks, which don’t
adversely affect quality of water and ensure freedom from microbiological growth. The
tanks shall be cleaned periodically and record maintained by the licensee in this behalf.
Only Purified Water shall be used for all the operations however potable water may be
used for washing and cleaning operations.
 Disposal of Waste: The disposal of sewage and effluents from the manufactory shall be
as required under the Environmental Pollution Control Board whereas all biomedical
waste shall be destroyed as per the provisions of the Biomedical Waste (Management and
Handling) Rules, 1996. Hazardous, toxic substances and flammable materials shall be
stored in suitably designed and segregated, enclosed areas in conformity with Central and
State Legislations.

2. Warehousing area
 Adequate areas shall be designed and provided
with proper racks, bins and platforms for the storage
and warehousing of all materials, products, machine
and equipment parts etc.
 Special storage conditions (e.g. temperature,
humidity) shall be provided, monitored and recorded,
where required.
 Receiving and dispatch bays shall protect materials
and products from adverse weather conditions.
 There shall be a separate sampling area in the
warehousing area for active raw materials and
excipients.
 Highly hazardous, poisonous and explosive
materials such as narcotic drugs and psychotropic
substances presenting potential risks of abuse, fire or
explosion shall be stored in safe and secure areas.
 Regular checks shall be made to ensure adequate
steps taken against spillage, breakage and leakage of
containers.
 Rodent treatment (pest control) should be done
regularly and at least once in a year and record
maintained.

3. Production area
 Working and in-process space shall be
adequate to permit orderly and logical
positioning of equipment and materials and
movement of personnel to avoid cross-
contamination and to minimize risk of
omission or wrong application of any of
manufacturing and control measures.
 In order to avoid the risk of cross-
contamination, separate dedicated and self-
contained facilities shall be made available
for the production of sensitive
pharmaceutical products like penicillin or
biological preparations with live
microorganisms.
 Pipe-work, electrical fittings, ventilation,
openings and similar service lines shall be
designed, fixed and constructed to avoid
accumulation of dust.

4. Ancillary area
 Rest and refreshment rooms shall be separate from other and shall not lead directly to the
manufacturing and storage areas.
 Facilities for changing, storing clothes and for washing and toilet purposes shall be easily
accessible and adequate for the number of users.
 Separate toilets for males and females not directly connected with production or storage
areas.
 Maintenance workshops shall be separate and away from production areas.
5. Quality control area
 QC laboratory shall be independent of the production areas and divided into separate
sections for physico-chemical, biological, microbiological and radio-isotope analysis.
 Arrangements like air-locks and laminar air flow station shall be provided in microbiology
section, if necessary.
 The laboratories shall be designed to avoid mix-ups and cross contamination.
 Separate air-handling units and other requirements shall be provided for biological,
microbiological and radioisotopes testing areas.

6. Personnel
7. Health, clothing and sanitation of workers
 The manufacture/testing shall be conducted under the direct supervision of competent
technical staff and head of the quality control laboratory shall be independent of the
manufacturing unit.
 The licensee shall ensure that all personnel in production area or into quality control
laboratories shall receive training appropriate to the duties and responsibility assigned to
them.
 Personnel for quality assurance and quality control operations shall be suitably qualified
and experienced.
All persons prior to and during employment shall be trained in practices that ensure
personnel hygiene.
 No person showing, at any time, apparent illness or open lesions shall be allowed to
handle starting materials, packaging materials, in-process materials and drug products.
 All personnel shall wear clean body coverings.
 Separate change rooms for either sex shall be provided before entry into manufacturing
area.
 Smoking, eating, drinking, chewing or keeping plants, food, drink and personnel
medicines shall not be permitted in production, laboratory, storage and other areas where
they might adversely influence the product quality.

8. Manufacturing operations and controls
9. Sanitation in manufacturing premises
 Trained personnel under the direct supervision of approved technical staff shall perform
each critical step in the process relating to the selection, weighing and measuring of raw
material addition during various stages.
 The content of all vessels and containers used in manufacturing and storage shall be
conspicuously labelled with the name of the product, batch no., batch size and stage of
manufacture.
 The manufacturing premises shall be cleaned and maintained in an orderly manner so
that it is free from accumulated waste, dust, debris and other similar material.
 A routine sanitation program shall be drawn and observed and recorded.
 A validated cleaning procedure shall be maintained.

11. Equipment
10. Raw material
 There shall be adequate areas for materials under test, approved and rejected wherever
necessary, under controlled temperature and humidity.
 All materials shall be stored in an orderly fashion to permit batch segregation and stock
rotation by a first in/first expiry, first out principle.
 Only raw material which have been released by the QC Department and which are
within their shelf-life shall be used.
 All the containers of raw material shall be placed on the raised platforms/racks and not
directly on the floor.
 The equipment shall be located, designed, constructed, adapted and maintained to suit
the operations to be carried out.
 The layout and design of the equipment shall aim to minimize the risk of errors and
permit effective cleaning and maintenance in order to avoid cross- contamination, build-
up of dust or dirt and any adverse effect on the quality of the products.
 Each equipment shall be provided with a logbook, wherever necessary.

12. Documentation and records
13. Quality assurance (QA)
 Documents shall be approved, signed and dated by appropriate and authorized persons.
 Records and associated SOPs shall be retained for at least one year after the expiry date of
the finished product.
 Data shall be recorded by electronic data processing systems or other reliable means but
Master Formulae and detailed operating procedures relating to the system in use shall also be
available in a hard copy to facilitate checking of the records.
 Access shall be restricted by ‘passwords’ or other means and the result of entry of critical
data shall be independently checked.
 Adequate arrangements are made for manufacture, supply and use of the correct starting
and packaging materials.
 Adequate controls on starting materials, intermediate products, and bulk products and
other in-process controls, calibrations and validations are carried out.
 The finished product is correctly processed and checked in accordance with established
procedures.

14. Packaging records
15. Standard Operating Procedures (SOPs) and Records
 Authorized packaging instructions for each product, pack size and type shall include the
following- (a) name of the product; (b) description of the dosage form, strength, composition
and pack size; (c) complete list of all the packaging materials required for a standard batch
size; (d) reproduction of the relevant printed packaging materials and specimens (e) a
reconciliation shall be made between number of labelling and packaging units issued,
number of units labelled, packed and excess returned or destroyed; upon completion of the
packing and labelling operation.
 There shall be written SOPs and records for- (a) the receipt of each delivery of raw,
primary and printed packaging material, (b) the internal labelling, quarantine and storage of
starting materials, packaging materials and other materials, (c) each equipment and
instrument, (d) sampling, (e) batch numbering, (f) testing, (g) records of analysis, (h)
reference samples (i) reprocessing and recoveries, (j) distribution records, (k) validation and
process validation, (l) product recalls, (m) complaints and adverse reactions, (n) export of
drugs

PART-I(A)- SPECIFIC REQUIREMENTS FOR MANUFACTURE OF STERILE
PRODUCTS, SVPs & LVPs, AND STERILE OPTHALMIC PREPARATIONS
 Dampness, dirt and darkness are to be avoided to ensure specific conditions in all areas.
 The building shall be built on proper foundation with standardized materials to avoid
cracks in critical areas like aseptic solution preparation, filling and sealing rooms.
 Water lines shall not pose any threat of leakage to aseptic area.
•ASEPTIC AREAS: Walls, floors and ceiling should be impervious, non-shedding, non-
flaking and non-cracking.
• Light-fittings and air-grills shall be flush with the walls and not hanging from the ceiling
so as to prevent contamination.
• There shall be no sinks and drains in Grade A and Grade B areas.
• Change room to the aseptic areas shall be clearly demarcated into black, gray and white
rooms with different levels of activity and air cleanliness.
• For communication between aseptic areas and non-aseptic areas, intercom telephones or
speak-phones shall be used.
• AIR HANDLING SYSTEM: The air system shall be provided the appropriate filters
such as for Grades A,B and C. The maximum permitted number of particles in the “at rest”
condition shall approximately be as under:
Grade A & B correspond with Class 100
Grade C corresponds with Class 10,000
Grade D corresponds WITH Class 100,000

• ENVIROMENTAL MONITORING: There shall be a written environment monitoring
program. The environmental parameters shall be verified and established at the time of
installation and monitored at periodic frequencies.
• GARMENTS: The garments shall be made of non-shedding and light weave material.
Cotton garments shall not be used. The garments shall shed virtually no fibers or particulate
matter. Gloves shall be made up of latex or other suitable plastic materials and shall be
powder free.
• SANITATION: There shall be written procedures for the sanitation of sterile processing
facilities. Air particulate quality shall be evaluated on a regular basis and records maintained.
• EQUIPMENT
• STERILIZATION
•DOCUMENTATION

PART-II- SPECIFIC REQUIREMENTS OF PLANT AND EQUIPMENT
 External preparation: A minimum area of 30sq m for basic installation and 10sq for
ancillary area is recommended. Areas for formulations meant for external use and internal
use shall be separately provided.
 Oral liquid preparation: A minimum area of 30sq m for basic installation and 10sq for
ancillary area is recommended.
 Tablets: A minimum area of 60sq m for basic installation and 20 sq m ancillary area is
recommended for uncoated tablets. A minimum area of 30sq m for basic installation and 10
sq m ancillary area is recommended for coated tablets.
 Powders: A minimum area of 30sq m for basic installation, an additional room for actual
blending and in the case of operation involving floating particles of fine powder, a suitable
exhaust system shall be provided.
 Capsules: A minimum area of 25 sq m for basic installation and 10 sq m for ancillary
area each for penicillin and non-penicillin sections is recommended.

 Surgical dressings: The following equipment is recommended for the manufacture of
surgical dressings other than Absorbent cotton wool: rolling machine, trimming machine,
cutting equipment, folding and pressing machine for gauze, mixing tanks for processing
medicated dressing, hot air dry oven.
 Ophthalmic preparations: A minimum area of 25 sq m for basic installation and 10
sq m for ancillary area for penicillin and non-penicillin sections is recommended.
 Pessaries and Suppositories: A minimum area of 25 sq m is recommended for basic
installation.
 Inhalers and vitrallae: A minimum area of 25 sq m is recommended for basic
installation.
 Repacking of drugs and pharmaceuticals: A minimum area of 35 sq m is
recommended for basic installation and a suitable exhaust system for operations
involving floating particles of fine powder.

 Parenteral Preparations
In glass containers: It shall be divided into the following separate areas-
(a) Water management area
(b) Containers and closures preparation area
(c) Solution preparation area
(d) Filing, capping and sealing area
(e) Sterilization area
(f) Quarantine area
(g) Visual inspection area
(h) Packaging area

 In plastic containers by FFS/BFS technology
It shall be divided into the following separate areas-
(a) Water management area
(b) Container moulding-filling and sealing area
(c) Solution preparation area
(d) Sterilization area
(e) Quarantine area
(f) Visual inspection area
(g) Packaging area
• A minimum area of 250 sq m for basic installation and 150 sq m for ancillary area
for LVP preparation in plastic containers by FFS technology is recommended. These
areas shall be partitioned into suitable enclosures with air-lock arrangements. Areas
for formulations meant for external use and internal use shall be separately provided to
avoid mix-up. Packaging materials for LVPs shall have a minimum area of 100 sq m.

GMP presentation.pptx

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GMP presentation.pptx