Pharmaceutical Quality affects every individual. Therefore GMP is required to ensure the quality of the particular drug or dosage form. In this presentation you will go through some basic information about cGMP and layout of buildings.

1. Objectives And Policies
Of cGMP, Layout Of
Buildings And Services
PRESENTED BY- SHARWARI A SAPATE
M. PHARMACY F Y
DEPARTMENT OF PHARMACEUTICS
AISSMS COLLEGE OF PHARMACY

2. Contents.
 GMP
 cGMP
 Importance of cGMP
 Objectives of cGMP
 Policy of cGMP
 Layout of buildings, services and equipment

3. GMP
 Good Manufacturing Practice is that part of quality
assurance which ensures that the products are
consistently produced and controlled to the quality
standards appropriate to their intended use and as
required by marketing authorisation.

4. Current good manufacturing practices
(cGMP)
 cGMP stands for current good manufacturing practices. Here current
stands for updating technology in GMP.
 Food and drug administration regulates the quality of pharmaceuticals
products very carefully. The main regulatory standard for ensuring
pharmaceuticals quality is cGMP.
 Consumer expect that each batch of medicines they take will meet
quality standards so that will be safe and effective.
 cGMP provides for system that assure proper design, monitoring and
control of manufacturing process, packing, holding of drug and
facilities.

5. Why are cGMP so important?
 A consumer usually cannot detect that the product is safe or
efficacious.
 Poor quality medicines are not only a health hazard, but a waste of
money.
 Therefore, it is important that a drugs are manufactured under
conditions and practices required by the cGMP regulations to assure
that the quality is built into the design and manufacturing process at
every step.
 Facilities that are in good conditions, equipment that are calibrated,
employees who are qualified and fully trained and process that are
reproducible, are few requirements to assure safety and efficacy.

6. Objectives of cGMP.
 cGMP’s seek to ensure that all the manufacturer’s of regulated products
effectively implement a range of manufacturing controls over the
development and manufacture of products, with objective of ensuring that
process outputs are of the highest quality and consistently remain so over
time.
 They are broad categories of requirements which a manufacturer must adhere
to, however, the specific methods of implementation may vary from one
manufacturer to another. For example, there must be document control and
document comply with cGMP’s. However each manufacturer will define their
own document control and revision process. The regulatory body can then
review the effectiveness of these procedures via audit.

7. Objectives of cGMP.
Ensure that
products are
consistently
manufactured
and controlled
to the specified
quality.
Concerned with
all aspects of
production and
quality control.
In the
manufacture of
cosmetic
products,
overall control
and monitoring
is required.
Ensure that the
consumer
receives
products of
specified
quality.

8. Policy Of cGMP
 The purpose of this policy is to ensure compliance with current good
manufacturing practice regulations of foods.
 It is the responsibility of all the involved personnel at every level of
the organisation to act immediately if a risk of violating this policy is
detected.
 Department Managers are accountable for compliance with this policy
and the General Manager has final authority concerning any GMP
issue.

9. Layout Of Buildings And Services And
Equipment.
 LAYOUT DESIGN
 ORGANISATION AND PERSONNEL
 BUILDINGS AND FACILITIES
 EQUIPMENT
 PRODUCTION AND PROCESS CONTROL
 PACKAGING AND LABELING CONTROL

10. Layout Design.
 The layout design should aim to
1. Minimise the risks of error
2. Permit effective maintenance
3. Avoid cross contamination, build-up of dust and dirt.
4. Avoid any adverse effect on the quality of products.
 TYPES OF FLOW
1. CIRCULAR FLOW
2. PARALLEL FLOW
3. CROSSOVER TRAFFIC

11. CIRCULAR FLOW.

12. PARALLEL FLOW

13. CROSSOVER TRAFFIC.

14. Organisation And Personnel.
 The establishment and maintenance of a satisfactory system of QA and the correct
manufacture and control of pharmaceutical products and active ingredients rely upon
people.
chairman
Managing
director
President
production
President
marketing
President QA
President
Finance
President
personal

15. Personal hygiene

16. Personal Hygiene.
 All personnel, prior or during employment, as appropriate, should
undergo health examination.
 A personnel must be trained in the practice of personal hygiene. A
high level of personal hygiene should be observed by all those
concerned with manufacturing processes.
 Direct contact should be avoided between the operator’s hands and
starting materials, primary packaging materials and intermediate or
bulk product.
 Smoking, eating, drinking, chewing and keeping plants, food, drinks,
etc. should not be permitted in production laboratory and storage
areas.
 Personal hygiene procedures including the use of protective clothing
should apply to all persons entering production area.

17. Buildings And Facilities
 Any building used in manufacture, processing, packaging or holding of
a drug product shall be of suitable size, construction and location to
facilitate cleaning maintenance and proper operations.
 There shall be separate or defined areas or such other control systems
for the firm’s operations during the course of the following procedures
are necessary to prevent contamination or mix ups.
 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.
 Holding rejected components, drug product containers, closures, and
labelling;
DESIGN AND CONSTRUCTION FEATURES

18.  Storage of release components, drug product containers, closures, and
labelling;
 Storage of in process materials;
 Manufacturing and processing operations;
 Packaging and labelling operations;
 Quarantine storage before release of drug products;
 Storage of drug products after release;
 Control and laboratory operations;
 Aseptic processing;

19. Lighting.
 Adequate lighting should be provided in all areas.

20. Ventilation, air filtration, air heating
and cooling
 Adequate ventilation shall be provided.
 Equipment for adequate control over air pressure, micro organisms,
dust, humidity and temperature shall be provided.
 Air filtration systems, including prefilters particulate matter air
supplies to production areas’
 Air handling systems for the manufacture, processing and packaging of
penicillin shall be completely separate from those of other drug
products of human use.

21. Plumbing –
 Potable water shall be supplied under continuous positive pressure in
plumbing system free of defects that could contribute to
contamination to any drug product.
Sewage and refuse –
 Sewage, trash and other refuse in and from the building and
immediate premises shall be disposed in safe and sanitary manner.
Washing and toilet facilities –
 Adequate washing facilities shall be provided including hot and cold
water, soap detergent, air driers or single-service towels, and clean
toilet facilities easily accessible to working areas.

22. Sanitation -
 Any building used in the manufacture, processing, packaging or
holding of a drug product shall be maintained in clean and sanitary
condition.
 There shall be written procedures assigning responsibility for
sanitation and describing in sufficient detail the cleaning schedules,
methods, equipment and material to be used in cleaning building and
facilities, such written procedures should be followed.
 Rodenticides, insecticides and fungicides shall be not used unless
registered and not used in accordance with the Federal Insecticides,
Fungicides, and Rodenticides Act (7 U.S.C. 135)

23. Equipment
Equipment
design, size and
locations
Equipment
construction
Equipment
cleaning and
maintenance
Automatic,
mechanical and
electronic
equipment

24. Equipment design, size and locations-
 Equipment used in the manufacturing, processing, packing or holding
of a drug product shall be of appropriate design, adequate size and
suitable location to facilities operation for its intended use and for its
cleaning and maintenance.
Equipment construction-
 Equipment shall be constructed so that surfaces that contact
components, in process material or drug products shall not be
reactive, additives or absorptive so as to alter the safety, identity,
strength, quality or purity of the drug beyond the official or other
established requirement.

25. Equipment cleaning and maintenance –
 Equipment shall be cleaned, maintained to prevent contamination.
 Written procedures shall be established and following for cleaning and
maintenance of equipment, used in manufacturing, processing,
packing, holding of drug product.
Automatic, mechanical and electronic equipment-
 Computers or related systems, may be used in the manufacturing,
processing, packing, and holding of a drug.
 It such equipment is used, it shall be routinely calibrated, inspected
or checked according to written program designed to assure proper
performance.

26. Reference
 Sharma P P, How to Practice GMPs, 7th edition, Vandana Publication,
page no 621-628.
 Current Good Manufacturing Practices by FDA.
http://www.fda.gov/food/guidanceregulation/cgmp/default.htm
 WHO GMP guidelines by WHO.
http://who.int/medicines/areas/quality/safety/qualityassurance/pro
duction/en