This seminar basically explains about GMP and cGMP. It explains about thecode of federal regulation (CFR). After studying this seminar, the reader will get a detail knowldege pf what is GMP, cGMp, objectives and policies of cGMP. all the part of CFR part 21 is discussed in detail. Here in this seminar, main focus is given on the layout of the buildings and the equipment and its maintenant part. Layout of building includes the building design, construction of building and the plans. The life stage of equipments, how tp select a equipment befor epurchase i.e purchase specifications and the cleaninga nd the maintenance part of the equipments with examples are discussed in detail.

1. Seminar on
Current Good Manufacturing
Practice( cGMP) focusing layout of
building and equipment and its maintenance
Under the guidance of
Dr. Abdul Baquee Ahmed,
Associate professor, GIPS,
guwahati.
Presented by
Alakesh Bharali ( Roll No 1)
M. Pharm 1st semester(Pharmaceutics)
GIPS, Guwahati

2. CONTENTS
Introduction
Code of Federal regulation(CFR)
Evolution of cGMP
Objectives
Policies
CFR part 21
Layout of building and services
Building design
Construction of building
2

3. CONTENTS
Equipments and its maintenance
Life stages of equipment
Selection of equipment
Purchase specification
Cleaning and maintenance
Summary
Conclusion
References
3

4. Introduction
 GMP is that part of QA, which ensures the products are
consistently produced and controlled to the quality
standards appropriate to their intended use and as required
by the marketing authorization.
 cGMP refers to the current good manufacturing practice
regulations enforced by the US FDA.
 cGMP provide for systems that assure proper design,
monitoring and control of manufacturing processes and
facilities.
 Adherence to the cGMP regulations assure the identity ,
strength, quality and the purity of drug products
4

5. Code of federal regulations(CFR)
Portion of FDA
Divided into 50 titles
Collection of final regulations published in the
federal register
Appears in the part 210 (title 21) as per
USFDA
5

6. Evolution of cGMP
 1941: Initiation of GMP( after sulfanilamide tragedy
in 1937)
 1957: Thalidomide tragedy
 1962: Kefauver-Harris Amendment act
 1963: Establishment of GMP for drugs( 1st
publication)
 1975: cGMP for blood and components final rule
 1978:cGMP for drugs and medical devices( Major
revision)
6

7. Objectives
To minimize contamination
To eliminate error
To ensure quality products
To reduce rejects, recalls
To satisfy customers
Company image and reputation
7

8. Policies
To design and construct the facilities and
equipments properly
Follow written procedures and instructions
Document work
Validate work
Monitor facilities and equipments
Protect against contamination
Control components and product related processes
Conduct periodic audits
8

9. CFR Part 21
Subpart A: General provisions
211.1. Scope
211.3. Definitions
Subpart B: Organization and personnel
211.22. Responsibilities of QC unit
211.25. Personnel qualifications
211.28. Personnel responsibilities
211.34. Consultants
9

10. Contdd..
Subpart C: Buildings and facilities
211.42. Design and construction features
211.44. Lighting
211.46. ventilation, air filtration, air heating and
cooling
211.48. Plumbing
211.50. Sewage and refuse
211.52. Washing and toilet facilities
211.56. Sanitation
10

11. Contdd..
Subpart D: equipment
211.63. Equipment design, size and location
211.65. Equipment construction
211.67. Equipment cleaning and maintenance
211.68. Automatic, mechanical and electronic
equipment
211.72. Filters
11

12. Contdd..
Subpart E: Control of components and drug
product containers and closures
211.80. General requiremets
211.82. Receive and storage of untested
components, drug product containers
211.84. Testing and approval or rejection of
components
211.89. Rejected components ,containers and
closures
12

13. Contdd..
Subpart F: Production and process control
211.100. Written procedures, deviations
211.101. Charge-in of components
211.103. Calculation of yield
211.105. Equipment identification
211.110. Sampling and testing of in process
materials and drug products
211.115. Reprocessing
13

14. Contdd..
Subpart G: Packaging and labeling control
211.112. Materials examination and usage criteria
211.125. Labeling issuance
211.130. Packaging and labeling operations
211.134. Drug product inspection
Subpart H: Holding and distribution
211.142. Warehousing procedures
211.150. Distribution procedures
14

15. Contdd..
Subpart I: Laboratory controls
211.160. General requirements
211.165. Testing and release for distribution
211.166. Stability testing
211.170. Reserved samples
211.173. Laboratory animals
211.176. Penicillin contamination
15

16. Contdd..
Subpart J: Records and reports
211.182. Equipment cleaning and use log
211.186. Master production and control records
211.188. BPR
211. 192. Production record review
211.194. Laboratory records
Subpart K: Returned and salvaged products
211.204. Returned drug products
16

17. Layout of buildings and services
Designed according to cGMP practice which
ensures:
Prevention of cross contamination
Proper air handling system
Proper cleaning and sanitary facilities
Proper lighting
Proper plumbing and proper washing
17

18. Contdd..
Layout
 Organized planned inter department and intra
department arrangement
 Proper layout helps in:
 Increase productivity
 Helps in proper utilization of men, material, money and
machines
Types of layout:
 Circular flow
 Parallel flow
 Cross over traffic
18

19. Contdd..
19

20. Contdd..
20

21. Contdd..
21

22. Building design
Location
Design
Construction
Adaptation
Maintenance
22

23. Contdd..
Adequate space for future extension
Availability of water supply(quality and quantity),
power, fuel sewage and waste stream removal
Availability of public transport
Proximity of undesirable activity
Accessibility of interrelated operation
Advocating for law to restrict undesirable
activities while allowing anticipated development
23

24. Contdd..
Principle:
Minimize risks of errors
Permit effective maintenance
Avoid cross contamination, build up of dirt and
dust
Avoid any adverse effect on the quality of
products
24

25. Contdd..
Design:
Process flow(circular,parallel and crosstraffic)
Material flow( Product, raw materials, wastes)
Personnel flow( Manufacturing personnel
maintenance personnel, QA and QC personnel)
Equipment flow
25

26. 26

27. Construction of building
Floor:
Sufficient resistance to abrasion, impact, acid
action and temperature
High strength and high performance concretes
Foundations for vibrating machinery should be
placed upon rock or firm ground and it should
be separated from adjacent floor to avoid
vibrations
27

28. Contdd..
Roof system:
Lightness, strength, water proofness,
insulation, fire resistance, cost, durability and
low maintenance charges
Factors to consider: insulating value,
acoustical properties, appearance from inner
side, weight and maintenance
28

29. Contdd..
Water:
Should meet WHO guidelines for drinking
water quality
If drinking water insufficient to ensure API
quality, the appropriate specifications for
physical/ chemical attributes, total microbial
counts, objectionable organisms, endotoxins,
are called for.
29

30. Contdd..
Lighting:
Adequate lighting should be provided in all
areas to facilitate cleaning, maintenance and
proper operations.
Sewage and Refuse:
Should be disposed of in a safe , timely and
sanitary manner
Containers and pipes for waste material should
be clearly identified.
30

31. Contdd..
Sanitation and Maintenance:
Rodenticides, insecticides, fungicides,
cleaning and sanitizing agents
Change of sanitizing and cleaning agents
weekly
31

32. 32

33. Equipments and its maintenance
Physical entity used to carry out a general or
specific activity
Can be a single piece or an integrated system
of group of equipment, ex: water mineralizing
plants, air handling unit
Quality of the manufactured product depends
on the suitability and level of technology of
the equipment.
33

34. 34

35. 35

36. 36

37. Life stages of equipment
Equipment management has a life cycle , and
GMP covers life cycle of the equipment
Starts with decision to purchase equipment and
ends with crapping or elimination
Life cycle consists of following stages:
Decision to purchase equipment
Purchase of equipment
Qualifying , installing and validating equipment
Using the equipment
37

38. Selection of equipment
Availability of spares and servicing.
Frequency and ease of maintenance will
significantly impact on productivity and even
quality.
Equipment breakdown during processing could
effect quality
Included in the maintenance evaluation should
be the cleanability of the equipment
Construction materials and design
38

39. Purchase specifications
Why the equipment is needed?
Which operation to be performed?
What capacity the equipment should have?
How the equipment will be cleaned
Do we have trained operations to operate this
operation?
39

40. Contdd..
Factors to be considered while purchasing:
Right source
Right quality
Right quantity
Right price
Right time
Right mode of transportation
40

41. 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:
Washing and cleaning equipment should be
chosen and used so as to prevent contamination
Defective equipment should be removed from
production and quality control or at least clearly
labeled as defective.
41

42. Contdd..
MHRA/TGA guidelines:
Repairs and maintenance operations should not
present any hazard to the quality of the
product.
Equipment cleaning should be maintained in
scheduled basis and that should be recorded in
proper way.
42

43. Contdd..
USFDA Guidelines:
Equipment shall be cleaned , maintained and
sanitized at appropriate intervals to prevent
malfunction or contamination that would alter
the safety ,identity , strength , purity of the
drug product
Written procedures showing date, time , batch
no. shall be established and followed .
43

44. 44

45. 45

46. 46

47. Summary
GMP IS ACTUALLY GOOD COMMON SENSE
Quality management
47
Quality assurance
GMP
Production and QC

48. Conclusion
GMP compliance is not an option.
Good practices covers all aspects of
manufacturing activities prior to apply
The role and involvement of senior
management is crucial
Is to meet quality standard of the product
48

49. References
Leon lachman, Herbert A. Lieberman, Joseph L.
kanig ,”The theory and practice of industrial
pharmacy” 3rd edition , 589-618
Gilbert S. banker, christopher T . Rhodes ,
“Modern Pharmaceutics,3rd edition, 547-554
James Swarbrick, James C. Boylon ,
“Encyclopedia of pharmaceutical technology”
volume 2, second edition, 1735-1752
Dr. Shyamala Bhaskaran (2016) , “ Industrial
pharmacy”, Birla publication, 4th edition, 315-347
49

50. Internet Links
https://www.epa.gov
https://www.yorks.karoo.net/aerosol/link4.htm
https://www.aboutaerosols.com/industry.php
https://www.en.wikipedia.org/wiki
www.bioscreen.com
( 8:15-10:30 pm ,27/9/2019)
50

51. THANK YOU
51