To compare GMP requirement of India, US and Europe for tablets.

Drug Regulation & Regulatory Authorities
Dept. Of Quality Assurance & Regulatory Affairs
L. J. Institute of Pharmacy, Ahmedabad. Page 1
EXPERIMENT NO: DATE:
AIM: To compare GMP requirement of India, US and Europe for tablets.
REFERENCES:
1) I. N. Krishna Teja, et al; “Compilation of key GMP requirements in India and
EU for tablet manufacturing companies”, Journal of Pharmaceutical and
Biomedical Sciences, 2011, vol. 11, issue 11(16). Available at URL https:// www.
Jpbms.info
2) Sujith Kumar, et al; “Compilation of key GMP requirements in us and Japan for
Tablet Manufacturing”, International Journal of Drug Development & Research,
October-December 2011, Vol. 3, Issue 4. Available at URL https://
http://www.ijddr.in/Dacuments/2/6.pdf
INTRODUCTION:
"Good manufacturing practice" or “GMP” is part of a quality system covering the
manufacture and testing of active pharmaceutical ingredients, diagnostics, foods,
pharmaceutical products and medical devices. GMPs are guidelines that outline the
aspects of production and testing that can impact the quality of a product.
Although there are a number of them, all guidelines follow a few basic principles.
1. Manufacturing processes are clearly defined and controlled. All critical processes are
validated to ensure consistency and compliance with specifications.
2. Manufacturing processes are controlled, and any changes to the process are evaluated.
Changes that have an impact on the quality of the drug are validated as necessary.
3. Instructions and procedures are written in clear and unambiguous language. (Good
Documentation Practices)
4. Operators are trained to carry out the processes and document procedures.

A. COMPILATION OF KEY GMP REQUIREMENTS IN INDIA OF TABLETS
MANUFACTURING
General requirements
 Location and surroundings
 Building and premises
 Water System
 Disposal of waste
Warehousing area
 Warehousing areas shall be designed and adapted to ensure good storage
conditions.
 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.
 Segregation shall be provided for the storage of rejected, recalled or returned
materials or products.
Production area
 The production area shall be designed to allow the production preferably in uni-
flow and with logical sequence of operations.
 Pipe-work, electrical fittings, ventilation openings and similar services lines shall
be designed, fixed and constructed to avoid creation of recesses.
Ancillary areas
 Rest and refreshment rooms shall be separate from other areas. These areas 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.

Quality control area
 Quality Control Laboratories shall be independent of the production areas.
Separate areas shall be provided each for physic-chemical, biological,
microbiological or radio-isotope analysis.
 The design of the laboratory shall take into account the suitability of construction
materials and ventilation. Separate air handling units and other requirements shall
be provided for biological, microbiological and radioisotopes testing areas.
Personnel
 The manufacture shall be conducted under the direct supervision of competent
technical staff with prescribed qualifications and practical experience in the
relevant dosage and / or active pharmaceutical products.
 The head of the Quality Control Laboratory shall be independent of the
manufacturing unit.
 Personnel for Quality Assurance and Quality Control operations shall be suitably
qualified and experienced.
 Number of personnel employed shall be adequate and in direct proportion to the
workload.
Health, clothing and sanitation of workers
 Prior to employment, all personnel, shall undergo medical examination including
eye examination, and shall be free from tuberculosis, skin and other communicable
or contagious diseases.
 A high level of personal hygiene shall be observed by all those engaged in the
manufacturing processes.
Manufacturing operations and controls
 All manufacturing operations shall be carried out under the supervision of
technical staff approved by the Licensing Authority. The contents of all vessels and
containers used in manufacture and storage during the various manufacturing
stages shall be conspicuously labeled with the name of the product, batch number,
batch size and stage of manufacture. Products not prepared under aseptic

conditions are required to be free from pathogens like Salmonella, Escherichia coli,
Pyocyanea, etc.
Sanitation in the manufacturing premises
 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.
 The manufacturing areas shall not be used for storage of materials, except for the
material being processed.
Raw materials
 The licensee shall keep an inventory of all raw materials to be used at any stage of
manufacture of drugs and maintain records as per Schedule U.
 All incoming materials shall be quarantined immediately after receipt or
processing and materials shall be checked to ensure that the consignment
corresponds to the order placed.
 All incoming materials shall be purchased from approved sources under valid
purchase vouchers.
 Raw materials in the storage area shall be appropriately labeled. Labels shall be
clearly marked with the following information:
a. Designated name of the product and the internal code reference, and
analytical reference number;
b. Manufacturer’s name, address and batch number;
c. The status of the contents and the manufacturing date, expiry date and re-
test date.
Equipment
 For effective operations, the tablet production department shall be divided into
four distinct and separate sections as follows:-
a. Mixing, Granulation and drying section.
b. Tablet compression section.
c. Packaging section (strip/blister machine wherever required).
d. Coating section (wherever required).

 The Coating section shall be made dust free with suitable exhaust system to
remove excess powder and fumes resulting from solvent evaporation.
 Area minimum additional area of thirty square meters for coating section for basic
installation and ten square meters for ancillary area is recommended.
 The manufacture of hypodermic tablets shall be conducted under aseptic
conditions in a separate air-conditioned room, the walls of which shall be smooth
and washable.
 The manufacture of effervescent and soluble/dispersible tablets shall be carried
out in air-conditioned and dehumidified areas.
Documentation and records
 Documents designed, prepared, reviewed and controlled, wherever applicable,
shall comply with these rules and approved, signed and dated by appropriate and
authorized persons.
 Documents shall specify the title, nature and purpose.
 The records shall be made or completed at the time of each operation in such a
way that all significant activities concerning the manufacture of pharmaceutical
products are traceable.
Quality assurance
 The system of quality assurance appropriate to the manufacture of pharmaceutical
products shall ensure that
a. The pharmaceutical products are designed and developed in a way that
takes account of the requirement of Good Manufacturing Practices and
other associated codes such as those of Good Laboratory Practices and
Good Clinical Practices
b. Adequate arrangements are made for manufacture, supply and use of the
correct starting and packaging materials.
c. The finished product is correctly processed and checked in accordance with
established procedures;
d. The pharmaceutical products are not released for sale or supplied before
authorized persons have certified that each production batch has been
produced and controlled in accordance with the requirements of the label

claim and any other provisions relevant to production, control and release
of pharmaceutical products.
Self-inspection and quality audit
 To evaluate the manufacturer’s compliance with GMP in all aspects of production
and quality control, concept of self-inspection shall be followed.
Validation and process validation
 Validation studies shall be an essential part of Good Manufacturing Practices and
shall be conducted as per the pre-defined protocols.
 A written report summarizing recorded results and conclusions shall be prepared,
documented and maintained.
 Processes and procedures shall be established on the basis of validation study and
undergo periodic revalidation to ensure that they remain capable of achieving the
intended results.
 When any new master formula or method of preparation is adopted, steps shall be
taken to demonstrate its suitability for routine processing.
 Significant changes to the manufacturing process, including any changes in
equipment or materials that may affect product quality and/or the reproducibility of
the process, shall be validated.
Specific requirements for manufacture of oral solid dosage forms (tablets)
 General: The processing of dry materials and products creates problems of dust
control and cross-contamination. Special attention is therefore, needed in the
design, maintenance and use of premises and equipment in order to overcome these
problems. Wherever required, enclosed dust control manufacturing systems shall
be employed.
 Sifting, Mixing and Granulation: Unless operated as a closed system, mixing,
sifting and blending equipments shall be fitted with dust extractors. Residues from
sieving operations shall be examined periodically for evidence of the presence of
unwanted materials.
 Compressions (Tablets): Each tablets compressing machine shall be provided
with effective dust control facilities to avoid crosscontamination. Unless the same

product is being made on each machine, or unless the compression machine itself
provides its own enclosed air controlled environment, the machine shall be
installed in separate cubicles.
 Coating (Tablets): Air supplied to coating pans for drying purposes shall be
filtered air and of suitable quality. The area shall be provided with suitable exhaust
system and environmental control (temperature, humidity) measures.
 Printing (Tablets): Special care shall be taken to avoid product mix-up during any
printing of tablets and capsules. Where different products, or different batches of
the same product, are printedsimultaneously, the operations shall adequately be
segregated.
 Packaging (Strip and Blister): Care shall be taken when using automatic tablet
and capsule counting strip and blister packaging equipment to ensure that all rogue
tablets, capsules or foils from packaging operation are removed afterbefore a new
packaging operation is commenced.
 Integrity of individual packaging strips and blisters shall be subjected to vacuum
test periodically to ensure leak profess of each pocket strip and blister and records
maintained.
B. COMPILATION OF KEY GMP REQUIREMENTS IN EU OF TABLETS
MANUFACTURING
Quality management
 The holder of a manufacturing authorisation must manufacture medicinal products
so as to ensure that they are fit for their intended use, comply with the
requirements of the marketing authorisation and do not place patients at risk due to
inadequate safety, quality or efficacy.
Quality assurance
 The system of Quality Assurance appropriate for the manufacture of medicinal
products should ensure that:
 Production and control operations are clearly specified and Good Manufacturing
Practice adopted;
 Arrangements are made for the manufacture, supply and use of the correct starting
and packaging materials.

 All necessary controls on intermediate products, and any other in-process controls
and validations are carried out;
 The finished product is correctly processed and checked, according to the defined
procedures;
Quality control
The basic requirements of Quality Control are that:
 Adequate facilities, trained personnel and approved procedures are available for
sampling, inspecting and testing starting materials, packaging materials,
intermediate, bulk, and finished products, and where appropriate for monitoring
environmental conditions for GMP purposes;
 The finished products contain active ingredients complying with the qualitative
and quantitative composition of the Marketing Authorisation, are of the purity
required, and are enclosed within their proper containers and correctly labelled;
 Records are made of the results of inspection and that testing of materials,
intermediate, bulk, and finished products is formally assessed against specification.
Product assessment includes a review and evaluation of relevant production
documentation and an assessment of deviations from specified procedures;
Product quality review
 Regular periodic or rolling quality reviews of all licensed medicinal products,
including export only products, should be conducted with the objective of
verifying the consistency of the existing process, the appropriateness of current
specifications for both starting materials and finished product to highlight any
trends and to identify product and process improvements. Such reviews should
normally be conducted and documented annually.
 Quality reviews may be grouped by product type, e.g. solid dosage forms, liquid
dosage forms, sterile products, etc. where scientifically justified.
 Where the marketing authorisation holder is not the manufacturer, there should be
a technical, agreement in place between the various parties that defines their
respective responsibilities in producing the quality review.

Personnel
 The heads of Production and Quality Control must be independent from each other.
In large organisations, it may be necessary to delegate some of the functions listed
in 2.5, 2.6 and 2.7. 2.4
 The duties of the qualified person(s) are fully described in Article 51 of Directive
2001/83/EC, and can be summarised as follows:
a. For medicinal products manufactured within the European Community, a qualified
person must ensure that each batch has been produced and tested/checked in
accordance with the directives and the marketing authorisation[2];
b. Key Personnel include the head of Production, the head of quality control, and if at
least one of these persons is not responsible for the duties described in article 51 of
Directive 2001/83/EC1, the qualified person(s) designated for the purpose. In large
organisations, it may be necessary to delegate some of the functions listed in 2.5,
2.6 and 2.7. 2.4 The duties of the qualified person(s) are fully described in
Articlem 51 of Directive 2001/83/EC.
Training
 The manufacturer should provide training for all the personnel whose duties take
them into production areas or into control laboratories and for other personnel
whose activities could affect the quality of the product.
 Continuing training should also be given, and its practical effectiveness should be
periodically assessed.
 Personnel working in areas where contamination is a hazard, e.g. clean areas or
areas where highly active, toxic, infectious or sensitising materials are handled,
should be given specific training.
 Visitors or untrained personnel should, preferably, not be taken into the production
and quality control areas.
Personnel hygiene
 Detailed hygiene programmes should be establishedand adapted to the different
needs within the factory. They should include procedures relating to the health,
hygiene practices and clothing of personnel.
 All personnel should receive medical examination upon recruitment.

 Every person entering the manufacturing areas should wear protective garments
appropriate to the operations to be carried out.
 Direct contact should be avoided between the operator’s hands and the exposed
product as well as with any part of the equipment that comes into contact with the
products.
Premises and equipment
 Premises and equipment must be located, designed, constructed, adapted and
maintained to suit the operations to be carried out.
 Premises should be situated in an environment which, when considered together
with measures to protect the manufacture, presents minimal risk of causing
contamination of materials or products.
Production area
 Premises should preferably be laid out in such a way as to allow the production to
take place in areas connected in a logical order corresponding to the sequence of
the operations and to the requisite cleanliness levels.
 Where starting and primary packaging materials, intermediate or bulk products are
exposed to the environment, interior surfaces (walls, floors and ceilings) should be
smooth, free from cracks and open joints, and should not shed particulate matter
and should permit easy and effective cleaning and, if necessary, disinfection.
 Drains should be of adequate size, and have trapped gullies.
Storage areas
 Storage areas should be of sufficient capacity to allow orderly storage of the
various categories of materials and products.
 Storage areas should be designed or adapted to ensure good storage conditions.
 Receiving and dispatch bays should protect materials and products from the
weather.
 There should normally be a separate sampling area for starting materials.
 Segregated areas should be provided for the storage of rejected, recalled or
returned materials or products.

Quality control areas
 Normally, Quality Control laboratories should be separated from production areas.
This is particularly important for laboratories for the control of biological,
microbiological and radioisotopes, which should also be separated from each other.
Sufficient space should be given to avoid mix-ups and cross-contamination.
 Special requirements are needed in laboratories handling particular substances,
such as biological or radioactive samples.
 Separate rooms may be necessary to protect sensitive instruments from vibration,
electrical interference, humidity, etc.
Ancillary areas
 Rest and refreshment rooms should be separate from other areas.
 Maintenance workshops should as far as possible is separated from production
areas.
 Animal houses should be well isolated from other areas, with separate entrance and
air handling facilities.
Equipment
 Manufacturing equipment should be designed, located and maintained to suit its
intended purpose.
 Repair and maintenance operations should not present any hazard to the quality of
the products.
 Washing and cleaning equipment should be chosen and used in order not to be a
source of contamination.
 Production equipment should not present any hazard to the products.
 Measuring, weighing, recording and control equipment should be calibrated and
checked at defined intervals by appropriate methods.
Documentation
 Good documentation constitutes an essential part of the quality assurance system.
 The legibility of documents is of paramount importance Specifications describe in
detail the requirements with which the products or materials used or obtained
during manufacture have to conform.

 Documents should not be handwritten; although, where documents require the
entry of data, these entries may be made in clear, legible, indelible handwriting.
Sufficient space should be provided for such entries.
 Data may be recorded by electronic data processing systems, photographic or other
reliable means, but detailed procedures relating to the system in use should be
available and the accuracy of the records should be checked. If documentation is
handled by electronic data processing methods, only authorised persons should be
able to enter or modify data in the computer and there should be a record of
changes and deletions; access should be restricted bypasswords or other means and
the result of entry of critical data should be independently checked.
 Batch records electronically stored should be protected by back-up transfer on
magnetic tape, microfilm, paper or other means. It is particularly important that the
data are readily available throughout the period of retention.
C. COMPILATION OF KEY GMP REQUIREMENTS IN US FOR TABLET
DOSAGE FORMS
Organization and Personnel
 Personnel engaged in the manufacture, processing, packing, or holding of a drug
product shall wear clean clothing appropriate for the duties they perform.
 Personnel shall practice good sanitation and health habits. Only personnel
authorized by supervisory personnel shall enter those areas of the buildings and
facilities designated as limited-access areas.
 Any person shown at any time (either by medical examination or supervisory
observation) to have an apparent illness or open lesions that may adversely affect
the safety or quality of drug products shall be excluded from direct contact with
components, drug product containers, closures, in-process materials, and drug
products until the condition is corrected or determined by competent medical
personnel not to jeopardize the safety or quality of drug products. All personnel
shall be instructed to report to supervisory personnel any health conditions that
may have an adverse effect on drug products.

Training
 Training must be approached with the seriousness of purpose that it needs and
deserves.
 The necessity for training arises whenever there is any deficiency in the
knowledge, understanding, attitudes and specific skills possessed by a person as
compared with the knowledge, understanding, attitudes and specific skills required
for the successful performance of any task assigned to that person.
 The new recruit, or a person newly transferred to a department, is almost certain to
display a deficiencyin one of more of these areas, and is thus a prime candidate for
training.
Operator Hygiene — Basic Guidelines
 It needs to be understood that good bodily hygiene and a high level of general
cleanliness are necessary in those working on the manufacture of pharmaceuticals
and similar products.
 Hands, including nails, should be kept clean, always be carefully washed after
visits to the toilet, before meals, and before work commences, or recommences
after a break. There is considerable risk of infection being passed on by
contaminated hands. To reduce the risk of infection through hand contact, the
following should be required of all operators:
a. Do not touch the product, nor objects that may come in contact with the
product, with unprotected hands.
b. Keep the hands well groomed with short, clean nails. Hands must be free of
any lesions, wounds, cuts, boils, or any other sources of infection.
c. Wrist watches, rings, or other jewellery should not be worn on the job.
d. Hands should be washed before work and as often as the job requires.
e. Protective gloves should be worn when working with open products and
when handling objects that come in direct contact with the product.
 Persons with infectious diseases or with open lesions on the body surfaces should
not work in production areas.
 A program for health checkups should operate for all production personnel. It
should provide for regular checkups in addition to a general medical examination
prior to employment.

Buildings and Facilities
 Any such building shall have adequate space for the orderly placement of
equipment and materials to prevent mix-ups between different components, drug
product containers, closures, labelling, in-process materials, or drug products, and
to prevent contamination.
 Operations shall be performed within specifically defined areas of adequate size.
There shall be separateor defined areas or such other control systems for the firm’s
operations as are necessary to prevent contamination or mix-ups during the course
of the following procedures:
a) Receipt, identification, storage, and withholding from use of components,
drug product containers, closures, and labelling, pending the appropriate
sampling, testing, or examination by the quality control unit before release
for manufacturing or packaging;
b) Holding rejected components, drug product containers, closures, and
labelling before disposition;
c) Storage of released components, drug product containers, closures, and
labelling;
d) Storage of in-process materials;
e) Manufacturing and processing operations;
f) Packaging and labelling operations;
 Adequate lighting shall be provided in all areas.
 Adequate ventilation shall be provided.
 Equipment for adequate control over air pressure, microorganisms, dust, humidity,
and temperature shall be provided when appropriate for the manufacture,
processing, packing, or holding of a drug product.
 Potable water shall be supplied under continuous positive pressure in a plumbing
system free of defects that could contribute contamination to any drug product.
Equipment Production and Process Controls
 There shall be written procedures for production and process control designed to
assure that the drug products have the identity, strength, quality, and purity they
purport or are represented to possess. Such procedures shall include all
requirements in this subpart. These written procedures, including any changes,

shall be drafted, reviewed, and approved by the appropriate organizational units
and reviewed and approved by the quality control unit.
 Written production and control procedures shall include the following, which are
designed to assure that the drug products produced have the identity, strength,
quality, and purity they purport or are represented to possess:
a) The batch shall be formulated with the intent to provide not less than 100 percent
of the labelled or established amount of active ingredient;
b) Components for drug product manufacturing shall be weighed, measured, or
subdivided as appropriate. If a component is removed from the original container
to another, the new container shall be identified with the following information;
i. Component name or item code;
ii. Receiving or control number;
iii. Weight or measure in new container;
iv. Batch for which component was dispensed, including its product name,
strength, and lot number.
 Weighing, measuring, or subdividing operations for components shall be
adequately supervised. Each container of component dispensed to manufacturing
shall be examined by a second person to assure that;
i. The component was released by the quality control unit;
ii. The weight or measure is correct as stated in the batch production records;
iii. The containers are properly identified.
iv. Each component shall be added to the batch by one person and verified by
a second person.
 Actual yields and percentages of theoretical yield shall be determined at the
conclusion of each appropriate phase of manufacturing, processing, packaging, or
holding of the drug product. Such calculations shall be performed by one person
and independently verified by a second person.
 All compounding and storage containers, processing lines, and major equipment
used during the production of a batch of a drug product shall be properly identified
at all times to indicate their contents and, when necessary, the phase of processing
of the batch.
 Major equipment shall be identified by a distinctive identification number or code
that shall be recorded in the Batch Production Record to show the specific

equipment used in the manufacture of each batch of a drug product. In cases where
only one of a particular type of equipment exists in a manufacturing facility, the
name of the equipment may be used in lieu of a distinctive identification number
or code.
 Valid in-process specifications for such characteristics shall be consistent with
drug product final specifications and shall be derived from previous acceptable
process average and process variability estimates where possible and determined
by the application of suitable statistical procedures where appropriate.
Examination and testing of samples shall assure that the drug product and in-
process material conforms to specifications.
 In-process materials shall be tested for identity, strength, quality, and purity as
appropriate, and approved or rejected by the quality control unit, during the
production process, e.g., at commencement or completion of significant phases or
after storage for long periods.
 Rejected in-process materials shall be identified and controlled under a quarantine
system designed to prevent their use in manufacturing or processing operations for
which they are unsuitable.
 When appropriate, time limits for the completion of each phase of production shall
be established to assure the quality of the drug product. Deviation from established
time limits may be acceptable if such deviation does not compromise the quality
of the drug product, such deviation shall be justified and documented.
 Appropriate written procedures, designed to prevent microbiological
contamination of drug products purporting to be sterile, shall be established and
followed. Such procedures shall include validation of any sterilization process.
 Reprocessing shall not be performed without the review and approval of the
quality control unit.
Labeling Issuance
 Strict control shall be exercised over labelling issued for use in drug product
labelling operations.
 Labelling materials issued for a batch shall be carefully examined for identity and
conformity to the labelling specified in the master or batch production records.

 Procedures shall be used to reconcile the quantities of labelling issued, used, and
returned, and shall requireevaluation of discrepancies found between the quantity
of drug product finished and the quantity of labelling issued when such
discrepancies are outside narrow preset limits based on historical operating data.
Such discrepancies shall be investigated in accordance with 211.192. Labelling
reconciliation is waived for cut or roll labelling if a 100% examination for correct
labelling is performed in accordance with 211.122(g)(2).
 All excess labelling bearing lot or control numbers shall be destroyed.
 Returned labelling shall be maintained and stored in a manner to prevent mix-ups
and provide proper identification.
 Procedures shall be written describing in sufficient detail the control procedures
employed for the issuance of labeling; such written procedures shall be followed.
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 labeling.
 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.
Returned and Salvaged Drug Products
 Returned drug products shall be identified as such and held. If the conditions
under which returned drug products have been held, stored, or shipped before or
during their return, or if the condition of the drug product, its container, carton, or
labelling, as a result of storage or shipping, casts doubt on the safety, identity,
strength, quality or purity of the drug product, the returned drug product shall be
destroyed unless examination, testing, or other investigations prove the drug
product meets appropriate standards of safety, identity, strength, quality, or purity.
A drug product may be reprocessed provided the subsequent drug product meets
appropriate standards, specifications, and characteristics. Records ofreturned drug
products shall be maintained and shall include the name and label potency of the
drug product dosage form, lot number (or control number or batch number),

reason for the return, quantity returned, date of disposition, and ultimate
disposition of the returned drug product. If the reason for a drug product being
returned implicates associated batches, an appropriate investigation shall be
conducted in accordance with the requirements of 211.192. Procedures for the
holding, testing, and reprocessing of returned drug products shall be in writing and
shall be followed.
Special Requirements for Solid Dosage Form Chemical Weighing
 Many Companies have adopted a central weighing department to service all of the
processing areas.
 The centralization of responsibility, the avoidance of duplicating weighing
facilities, and lower labour costs. After an item is weighed & properly initiated on
the batch sheet by the weighed.
 High-potency drugs such as steroids and alkaloid should be weighed in a separate
room equipped with absolute filters to avoid even minimal cross contamination.
This room could also be used for weighing dyes.
 Sinks and drain boards should be conveniently located to facilitate frequent
cleaning of measuring equipment. Cabinets should be provided for the storage of
utensils.
 Vacuum hoses should be available in the weighing area immediately adjacent to
the weighing booths so that the top of deems and other containers can be opened
for removal of contents.
Tablet Granulation and Compressing
 The numerous steps in granulation procedure increase the possibilities of cross-
contamination, incorrect product identification, and/or mix-ups. To eliminate these
possibilities, a separate room or booth is recommended for each step.
 Compartmentalizing the granulating process has, unfortunately, fragmented the
operation and increase space, capital, and labour costs. Granulation should be
considered a unit operation composed of closely integrated manufacturing steps,
and process development work should be directed to this area for cost reduction
and process improvement.

 Particular attention should be devoted to the cleaning of drying rack and trays,
which should be designed for easy cleaning and made of stainless steel or other
non-rusting material.
 If the department is not air-conditioned, all windows should be screened against
the entrance of insects.
 Room should have special low vapour transmission treatment of walls and should
be equipped with air locks.
 The booth walls should extend from floor to ceiling and may be made of tile up to
the four-foot or fivefoot level, with a glass or transparent partition extending it to
the ceiling.
 Space should also be provided for in-process testing equipment such as balances
and tablet hardness testers.
 There are two type of checks one is automatic and other is physical or manually.
 A major discrepancy between theoretic and actual yields signifies that an error
may have been introduced at some stage of the process.
Table 1: GMP as per the Countries.
INDIA
SCHEDULE M:- Schedule M of drug and cosmetic acts 1940 regarding GMP and
requirements of premises, plants
Part-I & Part I-B; specific requirements for manufacture of oral solid dosage forms (tablets
& capsules)
US FDA
FDA (Food and drug administration)
Part 210 — Current Good
Manufacturing Practice in Manufacturing & Part 211 discusses GMP requirements in
general.

COMPARISON OF GMP REQUIREMENTS OF INDIA, EUROPE AND USA
Table 2: Comparison of INDIA GMP, EU GMP AND US GMP guidelines
PARAMETER INDIA GMP EU GMP US GMP
Organization &
Personnel
suitably qualified and
experienced
Head of production,
Q.C &Q.A
The heads of
Production and Quality
Control
Qualified person
Personnel engaged in
the manufacture,
processing, packing, or
holding of a drug
product
Warehousing
area
ensure good storage
conditions
Segregation shall be
provided for the
storage of rejected,
recalled or returned
materials or products.
Storage areas should be
of sufficient capacity to
allow orderly storage of
the various categories
of materials and
products.
Storage areas should be
designed or adapted to
ensure good storage
conditions.
Equipment For effective Repair and maintenance Major equipment shall
EU
Two directives laying dow principles and guidelines of good manufacturing practice
(GMP) for medicinal products were adopted by the Commission in 1991, the first for
medicinal products for human use (Directive 91/356/EEC),the second one for veterinary
use (Directive 91/412/EEC). These guidelines describe GMP requirements in general and
not specifically for tablets.

operations, the tablet
production department
shall be divided into
four distinct and
separate sections as
follows:-
Mixing, Granulation
and drying section.
Tablet compression
section.
Packaging section
(strip/blister machine
wherever required).
Coating section
(wherever required).
operations should not
present any hazard to
the quality of the
products.
Washing and cleaning
equipment should be
chosen and used in
order not to be a source
of contamination.
be identified by a
distinctive
identification number or
code that shall be
recorded in the Batch
Production Record to
show the specific
equipment used in the
manufacture of each
batch of a drug product.
In cases where only one
of a particular type of
equipment exists in a
manufacturing facility,
the name of the
equipment may be used
in lieu of a distinctive
identification number or
code.
Production
area
The production area
shall be designed to
allow the production
preferably in uni-flow
and with logical
sequence of
operations.
Pipe-work, electrical
fittings, ventilation
openings and similar
services lines shall be
designed, fixed and
Premises should
preferably be laid out in
such a way as to allow
the production to take
place in areas
connected in a logical
order corresponding to
the sequence of the
operations and to the
requisite cleanliness
levels.

constructed to avoid
creation of recesses.
Quality control
area
Quality Control
Laboratories shall be
independent of the
production areas.
Separate areas shall be
provided each for
physic-chemical,
biological,
microbiological or
radio-isotope analysis.
Normally, Quality
Control laboratories
should be separated
from production areas.
This is particularly
important for
laboratories for the
control of biological,
microbiological and
radioisotopes, which
should also be
separated from each
other. Sufficient space
should be given to
avoid mix-ups and
cross-contamination.
Special requirements
are needed in
laboratories handling
particular substances,
such as biological or
radioactive samples.

To compare GMP requirement of India, US and Europe for tablets.

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