GMP Slide Share
GMP Slide Share
GMP Slide Share
JIJO THOMAS
M.PHARM PHARMACEUTICS
COLLEGE OF PHARMACEUTICAL
SCIENCES
TRIVANDRUM
CONTENTS
Introduction
Schedule M
Part I
Part II
Schedule M I
Schedule M II
Schedule M III
INTRODUCTION
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
required quality
US FDA GMP Regulation :
Section 21 of the CFR contains most regulations pertaining
to food and drugs
21 Code of Federal Regulations Part 210:
Current Good Manufacturing Practice in Manufacturing
Processing, packing, or Holding of Drugs.
21 Code of Federal Regulations Part 211: Current Good
Manufacturing Practice for Finished Pharmaceuticals.
16. QUALITY
CONTROL SYSTEM
• Quality control shall be concerned with sampling,
specifications, testing, documentation, release
procedures
• Materials are not released for use, nor products
released for sale or supply until their quality has
been judged to be satisfactory
16.1 QC lab should have qualified and experience staff
16.2 QC lab may be divided into Chemical, Instrumentation,
Microbiological and Biological testing
16.3 The QC department shall conduct stability studies of
the products to ensure and assign their shelf life. All records
of such studies shall be maintained
16.4 All instruments shall be calibrated and validated before
adopted for routine testing
16.5 Pharmacopoeia, reference standards, working
standards, references spectra, other reference materials
and technical books, as required, shall be available in the
QC Laboratory
17. SPECIFICATION
17.1 For raw materials and packaging materials
They shall include:
a) The designated name and internal code reference
b) Reference, if any, to a pharmacopoeial monograph
c) Qualitative and quantitative requirements with acceptance
limits
d) Name and address of manufacturer or supplier and original
manufacturer of the material
e) Specimen of printed material
f) Directions for sampling and testing or reference to
procedures
g) Storage conditions and
h) Maximum period of storage before re-testing
17.2 For finished products. Appropriate specifications
for finished products shall include:
a) The designated name of the product and the code
reference
b) The formula or a reference to the formula and the
pharmacopoeial reference
c) Directions for sampling and testing or a reference to
procedures
d) A description of the dosage form and package
details
e) The storage conditions and precautions, where
applicable
f) The shelf-life
18. MASTER FORMULA RECORDS
• There shall be Master Formula records relating to all
manufacturing procedures for each product and batch
size
• These shall be prepared and endorsed by head of
production and quality control
• The master Formula shall include:
a) the name of the product together with product
reference code relating to its specifications
b) the patent or proprietary name of the product along
with the generic name, a description of the dosage
form, strength, composition of the product and batch
size
c) name, quantity, and reference number of all the
starting materials to be used
d. A statement of the processing location and the
principal equipment to be used
e. detailed stepwise processing instructions and the
time taken for each step
f. the instructions for in-process control with their
limits
g. the requirements for storage conditions of the
products, including the container, labeling and
special storage conditions where applicable
h. any special precautions to be observed and
i. packing details and specimen labels
19. PACKING RECORDS
There shall be authorised packaging instructions for each
product, pack size and type
These shall include or have a reference to the following:
a) Name of the product
b) Description of the dosage form, strength and composition
c) The pack size expressed in terms of the number of
doses, weight or volume of the product in the final
container
d) Special precautions to be observed, including a careful
examination of the area and equipment in order to
ascertain the line clearance before the operations begin.
20. BATCH PACKAGING RECORDS
• A batch packaging record shall be kept for each batch or
part batch processed
• It shall be based on the relevant parts of the packaging
instructions, and the method of preparation of such records
shall be designed to avoid transcription errors
25.DISTRIBUTION RECORDS:
Records of distribution shall be maintained in a manner
such that finished batch of a drug can be traced to the
retain level to facilitate prompt and complete recall of the
batch, if and when necessary
26. VALIDATION AND PROCESS
VALIDATION:
• The process employed has been optimized , so that data
generated may be considered credible & evaluated for
consistency as well as relevance
• Validation studies shall conducted as per the pre-defined
protocols
• These shall include validation of processing, testing and
cleaning procedures
27. PRODUCT RECALLS:
• A prompt and effective product recall system of defective
products shall be devised for timely information of all
concerned stockiest, wholesalers, suppliers, up to the
retail level within the shortest period
• The licensee may make use of both print and electronic
media in this regard
28. COMPLAINTS AND
ADVERSE REACTIONS:
• All complaints thereof concerning product quality
shall be carefully reviewed and recorded according
to written procedures
• Reports of serious adverse drug reactions resulting
from the use of a drug along with comments and
documents shall be reported to the concerned
licensing authority
29. SITE MASTER FILE:
• It contains specific and factual GMP about the production
and/or control of pharmaceutical manufacturing preparations
carried out in the licensed premises
• It shall contain the following:-
General Information
Personnel
Premises
Equipment
Sanitation
Documentation
Production
Quality Control
Loan license manufacture and License
Distribution, Complaints and Product recall
Self Inspection & Export of Drugs
PART 1A: sterile products
• General :
Sterile products being very critical & sensitive in
nature, a high degree of precautions, prevention &
preparations are needed
Prescribed standards for supply of water, air, active
materials, maintenance of hygienic conditions
• Buildings and civil works:
Built of standardized material to avoid cracks in
critical areas
Manufacturing area clearly separated into support
areas, preparation areas, change areas and
aseptic areas
Aseptic area:
Walls, floors and ceilings should be impervious, non-
shedding & non-cracking
Walls shall be flat & ledges and recesses can be avoided
Ceilings shall be solid & joints shall be sealed
No sinks & drains in grade A & grade B areas
Doors made of aluminum or steel material & shall open
towards high pressure area
Separate exit space from the aseptic areas is advisable
Change rooms to aseptic areas shall be clearly
demarcated into black, grey & white rooms
• Air handling system:
Critical areas conforming to grade B,C & D have separate
air handling units
Documentation
PART 1B: oral solid
dosage forms
• General requirements:
Enclosed dust control manufacturing system shall be
employed
Suitable environmental conditions maintained by
installation of air- conditioning
Effective air-extraction system shall be provided with
discharge
Filters to retain dust to protect the local environment
• Sifting, mixing & granulation:
All equipments shall be fitted with dust extractors
Critical operating parameters like time &temperature shall
be specified in master formula
Monitored during processing & recorded in batch records
Granulation & coating solution- made, stored & used in a
manner to minimize contamination
Tablet compression:
Compressing machine – effective dust control facilities
Suitable labelling to prevent mix up of granules & tablets
on compression machinery
Tablets examined for appearance, wt. variation,
disintegration, hardness, friability & thickness
Tablet coating:
Air provided with suitable exhaust system &
environmental control
Air supplied to coating pans shall be filtered & of suitable
quantity
Filling of hard gelatin capsules
• Stored in conditions which ensure safety from effects of
excessive heat & moisture
Packaging
• Before packaging operation all ‘rogue’ tablets & capsules are
removed
• Strips - inspected for defects such as misprint, cut on foil,
missing tablets & improper sealing
PART 1C : oral
liquid dosage
forms
General:
Manufacture of MDI - minimum microbial & particulate
contamination
Building & civil works:
Located on a solid foundation to reduce risk of cracking walls &
floors
Environmental condition:
Where products or clean components are exposed, the area
shall be supplied with filtered air of grade C
Equipment:
Manufacturing equipment – closed system where vessels &
supply lines are stainless steel
Manufacture:
Approved master formula records are required for
manufacture of MDI
Primary packaging material – cleaned by compressed air
filtered through 0.2 micron filter
Filled containers shall be quarantined for a suitable period
to detect leaking containers
Documentation :
Temperature & humidity in the manufacturing area
Periodic filled weights of formulation
Records of rejections
PART 1F : APIs
External preparation:
Basic installation area: 30sq.m
Ancillary area: 10sq.m
Equipments include:
• Mixing & storage tank(stainless steel)
• Jacketed kettle(stainless container)
• Mixer
• A colloidal mill or suitable emulsifier
• A triple roller mill
• Liquid filling equipment
• Tube filling equipment
Oral liquid preparation:
Basic installation area:30sq.m
Ancillary area:10sq.m
Equipments include:
• Mixing & storage tanks
• Jacketed kettle
• Portable stirrer
• A colloidal mill
• Filtration equipment
• Semi automatic filling machine
• Pilfer proof cap sealing machine
• Water distillation unit deionizer
• Clarity testing inspection unit
Tablets:
Basic installation area :60sq.m(uncoated)
30sq.m(coated)
Ancillary area :20sq.m(uncoated)
10sq.m(coated)
Tablet production department classified into four
sections:
Mixing,
Tablet
granulatio
compressi
n & drying
on section
section
Coating
Packaging section
section (wherever
required)
Mixing, granulation & drying section:
• Disintegrator & sifter
• Powder mixer
• Granulator wherever required
• Thermostatically controlled hot air oven
• Weighing machines
Compression section:
• Tablet compression machine
• Punch & die storage cabinets
• Tablet de-duster
• Tablet inspection unit
• Dissolution test apparatus
• In-process testing apparatus
• Air conditioning & dehumidifier
Packaging section:
• Strip /blister packaging machine
• Leak test apparatus
• Tablet counters
• Air-conditioner & dehumidifier
Coating section:
• Jacketed kettle
• Coating pan
• Polishing pan
• Exhaust system
• Air conditioner & dehumidifier
• Weighing balance
Powders:
Basic installation area: 30sq.m
Equipments include:
• Disintegrator
• Mixer (electrically operated)
• Sifter
• Stainless steel vessels
• Filling equipment
Capsules:
Basic installation area: 25sq.m
Ancillary area:10sq.m
Equipments include:
• Mixing & blending equipment
• Capsule filling unit
• Capsule counters &
• Polishing equipment
Surgical dressing:
Basic installation area:30sq.m
Equipments include:
• Rolling & trimming machine
• Cutting equipment
• Folding & pressing machine for gauze
• Mixing tanks for processing medicated dressing
• Hot air dry oven
• Steam or dry heat sterilizer
Ophthalmic preparations :
Basic installation area : 25sq.m
Equipments include:
• Hot air oven
• Kettle
• Colloidal mill
• Tube filling equipment
• Mixing & storage tanks
• Seitz filter or sintered glass filters
• Liquid filling equipment
• Autoclaves
Pessaries & suppositories:
Basic installation area:20sq.m
Equipments include:
• Mixing & pouring equipment
• Molding equipment
• Weighing devices
Inhalers :
Basic installation area: 20sq.m
Equipments include:
• Mixing equipment
• Graduated delivery equipment
• Sealing equipment of medicament during filling
Repacking of drugs & pharmaceutical chemicals:
Basic installation area: 30sq.m
Equipments include:
• Sifter
• Stainless steel vessels
• Weighing & measuring equipment
• Filling equipment
• Electrical sealing machine
Parenteral preparation:
Basic installation area: 60sq.m(partitioned into
suitable sized cubicles with air lock arrangement)
Equipments include:
Manufacturing area:
• Storage equipment
• Washing & drying equipment
• Dust proof storage cabinet
• Water still
• Preparation & mixing tanks and equipments
• Filtering equipment
• Hot air sterilizer
General room:
• Inspection table
• Leak testing equipment
• Labelling & packaging unit
• Storage equipment including cold storage & refrigeration
SCHEDULE M-I Requirements of
factory premises of homoeopathic
preparations
1. General Requirements: Location and Surroundings;
Buildings; Water supply Health, Clothing and Sanitation
of Workers; Medical Services, container management
etc. comes under this.
2. Requirements of Plant and Equipment:
a) Mother tinctures and Mother solution Section- An
area of 55 sq. meters is recommended for basic
installations
b) Potentisation Section- Method of potentisation will
be adopted as specified in Homoeopathic
Pharmacopoeia of India Vol.I
SCHEDULE M-II : Requirement of premises for
manufacture of cosmetics
• General Requirements: Location and Surroundings; Buildings; Water
supply; Health, Clothing and Sanitation of Workers; Medical Services etc
• Requirements of Plant and Equipment: Specifications are given for
only certain cosmetic preparations like
a) Powers
b) Creams, lotions, emulsions, pastes, cleansing milks, shampoos,
pomade, brilliantine, shaving creams, and hair-oils etc
c) Nail Polishes and Nail lacquers
d) Lipsticks and lip-gloss
e) Depilatories
f) Preparations used for Eyes
g) Aerosol
h) Alcoholic Fragrance Solutions
i) Hair Dyes
j) Toilet Soaps
k) Tooth powders and toothpastes
SCHEDULE M-III Requirements of
factory premises for manufacture of
medical devices
General Requirements: Location and Surroundings;
Buildings; Water supply; Health, Clothing and Sanitation of
Workers; Medical Services etc comes under this
Requirements for Manufacture Of Medical Devices: Shall
be conducted bat the licensed premises, and the process of
manufacture is divided into following separate
operations/Sections-
a) Moulding
b) Assembling
c) Raw Materials
d) Storage Area
e) Washing, drying and sealing area
f) Sterilization
g) Testing facilities
cGMP