pharmaceutical quality assurance b pharma 6th sem Personnel objectives Personnel qualifications Personnel responsibilities Key personnel Responsibilities of the head of the production department Responsibilities of the head of quality control department Training Personnel hygiene Premises Layout of pharmaceutical industry Areas of premises Environmental control in sterile areas Equipment and raw materials Stages of equipment Cleaning and maintenance Raw materials Steps involved in purchase procedure Maintenance of stores  Storage conditions 

1. Himanshu Kamboj
Assistant Professor

2. CONTENTS
• Personnel objectives
• Personnel qualifications
• Personnel responsibilities
• Key personnel
• Responsibilities of the head of the production department
• Responsibilities of the head of quality control department
• Training
• Personnel hygiene
• Premises
• Layout of pharmaceutical industry
• Areas of premises
• Environmental control in sterile areas
• Equipment and raw materials
• Stages of equipment
• Cleaning and maintenance
• Raw materials
• Steps involved in purchase procedure
• Maintenance of stores
• Storage conditions

3. PERSONNEL OBJECTIVES
• To review requirements for key personnel
• To review the training of personnel
• To consider some specific issues

4. PERSONNEL QUALIFICATIONS
(a) Each person engaged in the manufacture, processing, packing, or holding of a drug
product shall have education, training, and experience, or any combination thereof, to
enable that person to perform the assigned functions. Training shall be in the particular
operations that the employee performs and in current good manufacturing practice as
they relate to the employee's functions. Training in current good manufacturing practice
shall be conducted by qualified individuals on a continuing basis and with sufficient
frequency to assure that employees remain familiar with CGMP requirements
applicable to them.
(b) Each person responsible for supervising the manufacture, processing, packing, or
holding of drug product shall have the education, training, and experience, or any
combination thereof to perform assigned functions in such a manner as to provide
assurance that the drug product has the safety, identity, strength, quality, and purity that
it purports or is represented to possess.
(c) There shall be an adequate number of qualified personnel to perform and
supervise the manufacture, processing, packing, or holding of each drug product.

5. PERSONNEL RESPONSIBILITIES
(a) Personnel engaged in the manufacture, processing, packing, or holding of a drug
product shall wear clean clothing appropriate for the duties they perform. Protective
apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to
protect drug products from contamination.
(b) Personnel shall practice good sanitation and health habits.
(c) Only personnel authorized by supervisory personnel shall enter those areas of the
buildings and facilities designated as limited-access areas.
(d) Any person shown at any time (either by medical examination or by 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.

6. PRINCIPLE
• The establishment and maintenance of a satisfactory
system of quality assurance and the correct
manufacture of medicinal products relies upon people.
• For this reason there must be sufficient qualified
personnel to carry out all the tasks which are the
responsibility of the manufacturer.
• Individual responsibilities should be clearly
• understood by the individuals and recorded.
• All personnel should be aware of the principles of
Good Manufacturing Practice that affect them and
receive initial and continuing training, including
hygiene instructions, relevant to their needs.

7. General
• The manufacturer should have an adequate number
of personnel with the necessary qualifications and
practical experience.
• The responsibilities placed on any one individual
should not be so extensive as to present any risk to
quality.

8. General
• The manufacturer must have an organization chart.
• People in responsible positions should have specific
duties recorded in written job descriptions and
adequate authority to carry out their responsibilities.

9. General
• There should be no gaps or unexplained overlaps in
the responsibilities of those personnel concerned
with the application of Good Manufacturing
Practice.
• All responsibilities and roles are defined in GMP in
Chapter 2 and Annex 16(certification by a qualified
person and batch release)

10. Key Personnel
• Key Personnel should possess the qualification of a
scientific education and practical experience required as
per national legislation.
• They are specialized in appropriate and combination of
chemistry or biochemistry, chemical engineering,
microbiology, pharmaceutical science and technology,
pharmacology and toxicology, and other related
science. Key Personnel include:
• The head of production
• The head of quality assurance
• The head of quality control

11. Responsibilities of the Head of the
Production Department
• to ensure that products are produced and stored
according to the appropriate documentation in order
to obtain the required quality
• to approve the instructions relating to production
operations and to ensure their strict implementation
• to ensure that the production records are evaluated
and signed by an authorized person before they are
sent to the Quality Control Department
• to check the maintenance of his department,
premises and equipment

12. • to ensure that the appropriate validations are done
• to ensure that the required initial and continuing
training of his department personnel is carried out and
adapted according to need.

13. Responsibilities of the
Head of Quality Control Department
• to approve or reject, as he sees fit, starting
materials, packaging materials, and intermediate,
bulk and finished products
• to evaluate batch records
• to ensure that all necessary testing is carried out
• to approve specifications, sampling instructions,
test methods and other Quality Control procedures
• to approve and monitor any contract analysts
• to check the maintenance of his department,
premises and equipment

14. • to ensure that the appropriate validations are done
• to ensure that the required initial and continuing
training of his department personnel is carried out
and adapted according to need.

15. Joint Responsibility
• the authorization of written procedures and other
documents, including amendments
• the monitoring and control of the manufacturing
environment
• plant hygiene
• process validation
• training
• the approval and monitoring of suppliers of materials
• the approval and monitoring of contract manufacturers
• the designation and monitoring of storage conditions for
materials and products
• the retention of records

16. • the monitoring of compliance with the requirements of
Good Manufacturing Practice
• the inspection, investigation, and taking of samples, in
order to monitor factors which may affect product
quality.

17. TRAINING
Trained personnel=quality performance
=Continual improvement
 Less prone to errors
 Less deviations from standards
 Reduce amount of rework
 Reduce amount of rejects

18. TRAINING
• The manufacturer should provide training for all the personnel
whose duties take them into production areas or into control
laboratories (including the technical, maintenance and cleaning
personnel), and for other personnel whose activities could affect
the quality of the product.
• Personnel working in areas where contamination is a hazard,
e.g. clean areas or areas where highly active, toxic, infectious or
sensitizing materials are handled, should be given specific
training.
• Visitors or untrained personnel should, preferably, not be taken
into the production and quality control areas. If this is
unavoidable, they should be given information in advance,
particularly about personal hygiene and the prescribed
protective clothing. They should be closely supervised.

19. PERSONNEL HYGIENE
• Detailed hygiene programs should be established
and adapted to the different needs within the
factory.
• They should include procedures relating to the
health, hygiene practices and clothing of
personnel.
• These procedures should be understood and
followed in a very strict way by every person
whose duties take him into the production and
control areas.

20. • All personnel should receive medical examination
upon recruitment.
• It must be the manufacturer’s responsibility that
there are instructions ensuring that health conditions
that can be of relevance to the quality of products
come to the manufacturer’s knowledge.
• Steps should be taken to ensure as far as is
practicable that no person affected by an infectious
disease or having open lesions on the exposed surface
of the body is engaged in the manufacture of
medicinal products.

21. • Every person entering the manufacturing areas
should wear protective garments appropriate to the
operations to be carried out.
• Eating, drinking, chewing or smoking, or the storage
of food, drink, smoking materials or personal
medication in the production and storage areas
should be prohibited

22. • 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.
• In general, any unhygienic practice within the
manufacturing areas or in any other area
where the product might be adversely
affected, should be forbidden.
• Personnel should be instructed to use the
hand-washing facilities.

23. PREMISES

24. INTRODUCTION
• Any building used in manufacturing, packaging or holding of drug product
must be located, design, constructed, adapted and maintained in such way
that operations to be carried out within them, done by fluency and ease
• The factory building used for manufacturing of drug product shall be so
situated and shall have such measures to avoid the risk of contamination
from external environment including open sewage, drain, public lavatory or
any other factory producing disagreeable or harmful fumes, odour, dust and
smoke, chemical or biological emission.
• The Premises/ building used for factory shall be designed, constructed,
adapted or maintained to suit the manufacturing and other operations so as
to permit production of drugs under hygienic conditions.
• The premises/ building shall conform to all conditions laid down in
Factories act 1948.
• The premises used for manufacturing, processing, warehousing, packaging,
labelling and testing should be compatible with manufacturing operations
carried out in same area.

25. LAYOUT OF PHARMACEUTICAL
INDUSTRY
Adequate space should be provided for logical and orderly placement of
equipment
and free movement of staff to avoid the risk of cross contamination.

26. • Proper drainage and waste disposal system should be there and the system
should be designed to avoid the back- flow and entry of rodents and insects
to the manufacturing areas.
• The walls and floors of the areas should be free from cracks to avoid dust
accumulation.
• The walls and floors should be smooth and washable to facilitate ease of
cleaning in the areas.
• Electric supply, lighting, temperature, humidity and ventilation should be
appropriate and such that they do not adversely affect directly or indirectly
either the pharmaceutical product during their manufacturing and storage of
the accurate functioning of the equipment.

27. AREAS OF PREMISES
1. Ancillary areas: Ancillary areas covers:
• Rest and Refreshment rooms.
• Toilets and Washrooms.
• Clothes storage areas.
• Changing rooms for employees.
• Rest and Refreshment Rooms should be separate from
other areas.
• Facilities for Toilets should not communicate directly with
production or storage areas.
• Areas for change rooms and storage of clothes and for
washing, and toilet purpose should be easily accessible and
appropriate for the number of users.

28. 2. Warehousing Areas
• Storage areas should have sufficient capacity to allow orderly storage of the various
categories of materials and products like:
i. Raw materials.
ii. Packaging Materials.
iii. Intermediates.
iv. Bulk and finished products.
v. Products in quarantine.
vi. Released, returned, rejected and recalled products.
• Storage areas should be designed to meet the required environmental conditions like:
Temperature and Humidity and Records of such environmental conditions monitoring
should be maintained.
• Separate sampling areas should be provided for active and raw materials, Such sampling
cubicles may be designed with suitable size and also provided with cleaning, drying and
storage for sampling tools.
• Sampling of liquid materials, solvents, flammable materials or toxic, poisons or potent
materials should be done in separate areas with taking all the necessary precautions for Safety
of people and materials both.
• All returned, rejected and recalled materials must be stored in lock and key and necessary
precaution should
• Printed packaging materials are considered critical to the conformity of the pharmaceutical
product to its labelling and special attention should be paid to the safe and secure storage
these materials.
• Dispensing areas should be separate for active and raw materials.

29. 3. Production Areas
• General category products (other than antibiotics, cytotoxic and hormones,)
should be manufactured in separate manufacturing facilities.
• Highly potent, sensitive or live micro-organism etc. should be produced in
separate areas to avoid cross contamination.
• Premises should be designed to have logical flow of materials, well organized
layout of plant and machinery and ease of cleaning, both equipment and facility.
• Depending on the volumes of materials being handled, adequate space should
be provided to avoid mix-ups.
• Production areas should be effectively ventilated with suitable designed HVAC
system appropriate to products being handled; to the operations undertaken and
to the external environment.
• Production areas should be regularly monitored during production and non-
production periods to ensure compliance with their design specifications.
• Premises for packaging of pharmaceuticals should be specifically designed and
out so as to avoid mix-up and cross contamination.

30. 4. Quality Control Areas
• Q.C. laboratories should be separate from production areas.
• Areas where biological, microbiological, or radio isotope test methods are employed
should be separate from each other.
• Q.C. laboratories should be designed to provide facilities for:
i. Chemical analysis
ii. Instrumental analysis.
iii. Microbiological and biological analysis etc.
iv. Storage for control samples, glassware's, chemicals, microbiological media books,
documents etc.
v. A separate room or area should be provided where highly sensitive instruments area
handled to protect them from electrical interference, vibration, contact with excessive
moisture, and other external factors.

31. Drainage system
• Potable water shall be supplied under continuous pressure in a
plumbing system free of defects that could contribute
contamination to any drug product.
• Water not meeting such standards of regulatory guidelines shall
not be permitted in the potable water system.
• Drains shall be of adequate size.
• Drainage should be connected directly to the sewer and it should
be provided with an air break or other mechanical devices to
prevent back Spoilage.
• Drainage system maintenance in the manufacturing facilities is
very critical from the Point of view of cleaning and sanitation of
the facilities.
• A detailed SOP should be there for cleaning and sanitation of
drains and their records should be maintained and reviewed
periodically.

32. Disposal of Waste
• Sewage, waste and biomedical waste in and from the building premises shall be
disposed of in a safe and sanitary manner according to the laws.
• The disposal of sewage and effluents (solid, liquid, and gas) from the
manufacturing premises should be done in conformity with the requirements of the
Environment Pollution Control Board.
• All biomedical waste shall be destroyed as per the provision of Bio-Medical Waste
and Handling) Rules, 1996.
• Additional precautions shall be taken for the storage and disposal of rejected drugs/
materials and all the Records shall be maintained for disposal of waste.
• Provisions shall be made for proper and safe storage of waste materials awaiting
disposal.
• 'Hazardous, harmful, toxic substances and inflammable materials shall be stored in
suitably designed and separate enclosed areas in conformity with Central and State
Legislation.
• Records of all disposed material must be kept and should be available for
inspection or audit when required.

33. MAINTENANCE
• Any building, premises used in the manufacture, processing, packing or storage of a drug
product shall be in a good state of repair.
• Facility maintenance includes maintenance of following things:
i. Leakage from ceiling or other surfaces.
ii Leakages from pipe lines of waters, steam, gases etc.
iii. Plumbing problems.
iv. Loose or broken tiles.
v. Improper closing of doors, windows.
vi. Improper electrical wiring
vii Improper electrical fittings/ fixtures.
• A detailed check list may be prepared for maintenance.
• During routine inspection of the facilities the deficiencies should be identified and corrected
immediately and the facility must always be maintained in a state of good.
• Deterioration of building and facilities represents poor image of facilities and it can affect
product quality.
• Cracks/ holes in walls, ceilings etc. can provide access to the rodents, insects,
microorganisms and it can directly affect the quality of the product, sanitation and hygiene.
• Roof leakage can affect the quality of materials and may cause damage to the equipments.
• Hence all the facilities should be checked regularly and maintained and records related to it
should be maintained.

34. SANITATION
• "Any building/premises used in the manufacture, processing, packing or holding
o a drug product shall be maintained in a clean and sanitary condition".
• All the premises shall be free of infestation by rodents, birds, insects, and other
vermin' (other than laboratory animals).
• There shall be written procedures assigning responsibility for sanitation and
describing in sufficient detail the cleaning schedules, methods, equipment and
materials to be used in the cleaning the buildings and facilities; such written
procedures shall be followed
• There shall be written procedures for use of suitable Rodenticides, insecticides,
fumigating agents and cleaning and sanitising agents.
• Such written procedures shall be designed to prevent the contamination of
equipment, components, drug product container and closures, packaging, labelling
material or drug products and shall be followed.
• Rodenticides, insecticides, and fungicides shall not be used unless registered and
used in accordance with the Federal Insecticides, Fungicides and Rodenticide Act.
• Sanitation procedures shall apply to work performed by contractors or temporary
employees as well as work performed by full time employee during the ordinary.

35. • SOPs should be available even for cleaning and sanitation of external areas of
the facilities like roads, lawns etc.
• In pharmaceutical industries, operations have to be carried out in clean areas to
avoid contamination, cleaning of areas, equipments and microbial monitoring,
disinfection of areas and equipments are very important and have to be carried
out regularly.
• In order to maintain sanitation and cleaning we have to consider following
points
i. Create and maintain safe working environment.
ii. Remove dust and dirt which can affect product quality.
iii. Minimize the risk of cross-contamination occurring between products.
iv. Lastly, reduce the levels of microbial contamination.

36. ENVIRONMENTAL CONTROL IN STERILE
AREAS
Sterile products are very critical and sensitive in nature hence it
requires very high degree of precaution and prevention is required
in its preparation and there shall be strict compliance with
standards prescribed by regulatory authorities.
1. Air handling units for sterile product manufacturing shall be
different from those of other areas.
2. Critical areas such as aseptic filling areas, sterilised
components unloading areas and changing room should conform
to grades B, C and D respectively and shall have separate "Air
handling units". The filter configuration in the Air handling unit
shall be suitably designed to achieve the grade of air

37. 3. For products which are filled aseptically, the filling room shall meet Grade
B condition
at rest.
4. The Filling operation shall take place under Grade A condition which
shall be demonstrated under working of simulated conditions which shall be
achieved by providing Laminar air Flow work station with suitable HEPA
Filters.
5. For products which are terminally sterilized, the filling room shall meet
Grade C conditions.
6. Manufacturing and component preparation areas shall meet Grade C
conditions.
7, After Completion of preparation, Washed components and vessels shall
be protected With
Grade C background.
8. The minimum air changes for Grade B and Grade C areas shall not be
less than 20 air changes per Hour in a room with good air flow pattern and
appropriate HEPA filters.
9. For Grade A Laminar air Flow work stations, the air flow rates shall be
0.3 meter per second (For Vertical air flow) and 0.45 meter per second (For
Horizontal ail flow).
10. Differential pressure between areas of different environmental shall be

38. 11. Unless there are product specific requirements, temperature and humidity in the
Aseptic areas shall not exceed 27◦C and 55% Relative Humidity respectively.
12. All the parameters listed above shall be verified and monitored at regular
periodic intervals.
13. Recommended frequencies for Periodic monitoring shall be as follows:
• Particulate monitoring in Air : 6 monthly
• HEPA Filter integrity testing : Yearly
• Air Change Rates : 6 Monthly
• Air Pressure differential : Daily
• Temperature and Humidity : Daily
• Microbial monitoring : Daily
14. There shall be written environmental monitoring programs and Microbiological
shall be recorded.

39. UTILITIES AND MAINTENANCE IN STERILE AREAS
• Sterile areas/ aseptic processing areas should have:
1. Smooth and easily cleanable Floors, 'Walls and Ceilings.
2. Temperature and humidity controls.
3. Air supply with HEPA filters under positive pressure.
4. Environmental conditions monitoring system.
5. A system for Cleaning and disinfecting to produce aseptic/ sterile conditions.
• Floors, walls and ceilings of sterile areas should be subjected to intensive and
frequent cleaning and sanitation.
• Floors, walls and ceilings of sterile areas should be composed of smooth and hard
surfaces with minimum joints and should be resistant to abrasion.
• Temperature and humidity in the sterile areas should be controlled and maintained
according to operations performed (68◦F temperature and 45% Relative Humidity is
suitable).
• The air in sterile areas should be provided by air supply fitted with HEPA filters (less
than 100 particles of 0.5 Micron with Not more than I Cfu/cm3); air flow rate 90 feet/
minute is recommended.
• Sterile areas should have positive differential pressure related to adjoining areas
and "Air pressure differentials should be monitored automatically.
• HEPA filters should be tested at regular intervals.
• Cleaning and disinfection of sterile areas, Facilities and equipments should be done
regularly and procedure used for cleaning and disinfection must be validated with
respect to both removal of previous product contamination and effective disinfection,
disinfectant should be changed periodically to minimise the possibility of microbial

40. CONTROL OF CONTAMINATION IN STERILE AREAS
• There are two main Sources of Contamination i.e. Area/Facilities and People.
1. Control of Contamination — Areas/Facilities
i. In the areas/ Facilities where sterile products are manufactured air should be supplied
under positive differential pressure with HEPA filters designed to keep Microorganisms and
other particles at low level.
ii. In sterile areas all the surfaces of floors, walls, ceilings etc should be hard and free from
cracks to avoid dust and microorganism accumulation and should permit easy cleaning.
iii. Access to sterile areas must be Controlled/ Restricted to people and entry and exit to
sterile areas should be only permitted through change areas.
2. Control of Contamination — People
All the personnel working in aseptic/sterile areas should emphasize on following points to
control the contamination:
i. Keep Body, hair, face, hands and nails clean.
ii. Report illness, injury, respiratory and skin problems. iii. Follow the written changing and
wash-up procedures.
iii. Do not use cosmetic and wear jewellery and wrist watches.
iv. Do not take papers and documents in sterile area.
v. Avoid eating, chewing, drinking and smoking in sterile areas.
vi. Avoid coughing and sneezing (If it is unavoidable, please leave the sterile area).
vii. Use gloves and disinfect them regularly.
viii. Follow the written changing and wash-up procedures.

41. ix. Always check on worn and damaged garments.
x. Unless there is a special hazard, do not pick anything from floor.
xi. Keep talking to the minimum while working in sterile areas.
xii. Do not move vigorously, always move gently and steadily.
3. Control of contamination by cleaning and disinfection
i. The written procedures regarding Cleaning and disinfection should be followed
exactly and strictly.
ii. Before disinfection, it is necessary to clean the area completely.
iii. All the cleaning and disinfecting agents and materials themselves should be clean.
iv. Avoid cleaning by mops use equipments.
v. Use vacuum cleaners for sucking dust.
vi. Always start cleaning walls and ceiling from top to avoid recontamination.
vii. Special care should be taken for selecting right Cleaning and disinfecting agents in
right dilution.
viii. All the equipments and accessories must be cleaned after used and stored in clean
dry place.
ix. Split materials such as liquids, Powders should be cleaned in such a way to
minimize the risk of further contamination and if there is a chance of contamination,
clean and disinfect that place.

42. Equipment and raw materials
•Equipment may be defined as a physical entity which is
used to carry out a general or specific activity in the
pharmaceutical plant.
• It can be a single piece, for example compression,
weighing machine.
• Equipment is an integrated system that is, group of
equipment come together to perform single activity.
e.g.: water mineralizing plants, air handling systems.
• Equipment is generally one of the major inputs along
with people facilities, materials, and systems

43. •The quality of the manufactured product much depends on the suitability,
and level of the technology of the equipment used since it is major
requirement in the manufacture of the pharmaceutical products.
• The regulatory literature on GMP in various countries gives enough
importance and provide guide lines on the management of equipment in
pharmaceutical plants.
• we have a glance on international GMP literature following points
coming up, those are:
- Location and design
- Preventive and breakdown maintenance
- Construction
- Size and adaptation
- Cleaning and cross contamination
- Installation and calibration
- Qualification and validation
- Automatic, mechanical, electronic equipment

44. Stages of equipment
• Equipment management in the pharmaceutical industry
has a life cycle, and the GMP requirement cover the life
cycle of equipment.
• It starts with decision to purchase equipment and ends
with scrapping or elimination of equipment from
operation.
• Decision to purchase equipment is primarily need based.
• It consists of following stages:
- decision to purchase equipment
- purchase of equipment
- qualifying, installing and validating equipment
- using the equipment

45. Selection of equipment
1. Availability of spares and servicing.
2. The frequency and ease of maintenance will
significantly impact on productivity and even quality.
3.Equipment breakdown during processing could
adversely affect quality. Included in the maintenance
evaluation should be the cleanability of the equipment.
4.This will involve accessibility to the parts to be
cleaned and the relative ease of disassembly and
reassembly process.
5. Environmental issues are important constraints. Is the
design of the equipment conductive to the application?
Such attributes as the ability to contain toxic products,
the ability to maintain aseptic conditions, etc. need to be
reviewed.

46. 6. Construction materials and design.
7. The type of process controls such as automatic
weight adjustment on tablet

47. Purchase specification
Before we take decision to purchase an equipment we
need to look many aspects.
• This primarily helps the user requirement specification
for the equipment.
• Following questions may arise in relation to design,
size, location, adaption and construction of the
equipment.
• Why the need arises for the purchase of equipment e.g.
Creation of new facility, increasing capacity, Adapting
to new and improved technology
• Which operations we want perform with proposed
equipment

48. • For example, equipment capability analysis, granulation,
sterilization .
• What capacity the equipment should have in terms output
and holding? E.g. ten lakh tablets per shift or ten thousand
litters of liquid.
• How the equipment will be cleaned? And also need to
consider that do we face any problem in validating the
cleaning process of the equipment?
•Do we have trained operators to operate this equipment?
Or whether the manufacturer helps in training our existing
operator.
• What will be the starting and stopping time of the
equipment?

49. Following factors are taken into consideration while
purchasing the materials:-
• Right source
• Right quality
• Right quantity
• Right price
• Right time
• Right mode of transportation

50. WHO guidelines
•Equipment must be located, designed, constructed,
adapted and maintained to suit the operation to be
carried out.
• The layout and design of the equipment must aim to
minimize the risk of errors and permit effective cleaning
and maintenance in order to avoid cross contamination,
buildup dust or dirt and in general any adverse effect on
the quality of the product.
• Equipment should be installed in such way as to
minimize any risk of error or of contamination.
• Production equipment should be designed, located,
and maintained to serve its intended purpose.

51. • Production equipment should be designed, so that it can
be easily and thoroughly cleaned on scheduled basis.
• Production equipment should not present any hazard to
the products.
• The parts of the production equipment that come in to
contact with the product must not be reactive ,additive or
absorptive to an extent that would affect the quality of the
product.
• The equipment must designed to be compatible with
most materials and process being used.

52. Equipment identification
• Identification is one of the four quality attributes in the
quality of pharmaceutical products.
• The identity of equipment is also important along with
the other identifications required just like, product,
room, people, system.
• Hence to meet this GMP requirement all equipment
must be clearly identified.

53. Cleaning And Maintenance:
• Use of cleaned equipment is one of the basic step in
avoiding contamination and meeting the purity of the
product.
WHO guidelines:
•The layout and design of the equipment must 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.
•Washing and cleaning equipment should be chosen and
used so as to prevent source of contamination.
• Defective equipment should, if possible be removed
from production and quality control or at least clearly
labeled as defective.

54. Raw materials
All materials that used into the manufacturing of a
finished bulk (even though it may not be present in final
product e.g. Certain solvents etc.) and which are
consumed by person using it are called as raw materials.
Raw materials can be either active drug or inactive
substances.
eg. Hard gelatin capsules: even though it is used to
fill the blend of medicine, it is not considered as
package materials because it is consumed by person 3
using medicines.

55. Purchase specification
• Written guidelines that precisely define the
operational, physical, and/or chemical
characteristics, as well as the quality and quantity of
a particular item to be acquired. rawmaterial.doc
• Mode of purchasing :
• By inspection
• By sample
• By description of brand
• By grading

56. Steps involved in purchase
procedure
1. Purchase requisition
2. 2. Selection of supplies
3. Inviting Quotation
4. Placing the order
5. Receiving the material
6. Checking of invoice or bill
7. Recording of bills in books
8. Releasing the payment to the supplier

57. Staff involved in purchasing have a particular and
thorough knowledge of products and suppliers.
Raw material can be purchased from supplier named
in relevant specification or directly from producer.
Specification established by manufacturer for the
starting materials be discussed with suppliers.
Pharmacist or chemist, who is familiar with quality
requirement of various material purchase department
can be head of purchase department

58. Maintenance of stores
Storage Area Specifications :-
- Sufficient Capacity
- Clean, Dry and Maintained within acceptable temp.
limit
- Designed and equipped reception area
- Ensuring of quarantine status
- Separate sampling area
- Segregation for storage of rejected, recalled or
returned material
- Safe and secure area for narcotics and highly active,
dangerous and risky material
- First in First out rule (FIFO) - First expiring First
Out (FEFO)

59. Storage conditions
- Room temp. Should be 30° C and R. H. 60%
- A.C storage (25± 2 ° C & R.H. 45 – 55%)
- Low temp. storage 2 – 8 ° C
- Separate area for Sterile product storage in A.C
- Light sensitive material in amber color container
- Hermitically sealed container
- Labeling of material in storage area
- Designated name of product and internal code
reference
- Batch no. given by supplier
- Status of Content8
- Expiry date or date beyond which retesting is
necessary

60. THANK YOU