Basic cGMP

This slide is helpful for Healthcare sector people.

1. BISHNU PADA SARKER
6/24/20201
BASIC CURRENT GOOD
MANUFACTURING PRACTICES
(cGMP)

2. Definitions
6/24/20202
What is GMP?
GMP is a common term and its full form is
Good Manufacturing Practice
GMPisthatpartofQualityAssurancewhich
ensuresthatmedicinalproductsareconstantly
producedandcontrolledtothequality
standardappropriatetotheirintendeduse.It
isconcernedwithbothProductionandQuality
Control.
It’s a magic key that opens the door to
quality.

3. HOW MANY GMPs?
British GMP-Good Pharmaceutical Manufacturing
Practice (GMP)
United States GMP-Current Good Manufacturing
Practices for Finished Pharmaceuticals (cGMP)
WHO GMP-Good Practices in the Manufacture
and Quality Control of Drugs
ASEAN GMP-ASEAN Good Manufacturing
Practice of Drugs
6/24/20203

4. 6/24/20204

5. QA, GMP & QC inter-relationship
QA is the sum total of the organized
arrangements with the objective of ensuring that
products will be of the quality required for their
intended use.
GMP that part of Quality Assurance aimed at
ensuring that products are consistently
manufactured to a quality appropriate to their
intended use
QC is that part of GMP concerned with sampling,
specification & testing, documentation & release
procedures which ensure that the necessary &
relevant tests are performed & the product is released
for use only after ascertaining it’s quality
6/24/20205

6. Definitions
What is cGMP?
cGMP refers to Current Good Manufacturing Practices
regulation enforced by USFDA
According to FDA:
the"C"incGMPstandsfor"current,"requiring
companiestousetechnologiesandsystemsthatareup-to-
dateinordertocomplywiththeregulations.Systemsand
equipmentthatmayhavebeen"top-of-the-line"toprevent
contamination,mix-ups,anderrors10or20yearsago
maybelessthanadequatebytoday'sstandards.
6/24/20206

7. Why c is small?
c is a variable in cGMP that’s why it is written in
small letter just like pH…p is variable potential in pH
6/24/20207

8. cGMP
6/24/20208

9. cGMP
6/24/20209
cGMPremindsmanufacturerthattheymustemploy
thetechnologiesandsystemswhichareuptodatein
ordertocomplywiththecurrentregulations.
GMPhastobeupdatedtimetotimeinorderto
complywiththestandardguidelines.
cGMP is a unique term to define most recent
guidelines with improvement and additions.

10. cGMP
Even if any product meets the specification but cGMP
is not followed, the product is then considered
“adulterated” by the law.
It is important to note that cGMPs are minimum
requirements.
6/24/202010

11. 6/24/202011
TheCodeofFederalRegulations(CFR)isthecodificationofthegeneralandpermanentrulesand
regulations(sometimescalledadministrativelaw)publishedintheFederalRegisterbythe
executivedepartmentsandagenciesofthefederalgovernmentoftheUnitedStates.TheCFRis
dividedinto50titlesthatrepresentbroadareassubjecttofederalregulation.
Title 21 is the portion of the Code of Federal Regulationsthat governs food and drugs within the
United Statesfor the Food and Drug Administration(FDA), the Drug Enforcement Administration
(DEA), and the Office of National Drug Control Policy(ONDCP).

12. What is GxP?
A general term for Good Practicequality
guidelines and regulations. These guidelines are
used in many fields, including the pharmaceutical
and food industries.
The titles of these good practice guidelines
usually begin with "Good" and end in "Practice",
with the specific practice descriptor in between
6/24/202012

13. What is GxP?(continued…)
•GxPrepresents the abbreviations of these titles,
where x(a common symbol for a variable)
represents the specific descriptor.
•Good Automated Manufacturing Practice, or
GaMP
•Good Clinical Practice, or GCP
•Good Distribution Practice, or GDP
•Good Documentation Practice, or GDP
•Good Laboratory Practice, or GLP
•Good Manufacturing Practice, or GMP
•Good Storage Practice, or GSP
6/24/202013

14. Essence of cGMP for pharmaceuticals product
6/24/202014
Initially-the assurance of the quality of the
medicinal product.
Ultimately-the safety, well being and
protection of the patient.

15. History of GMP & cGMP
6/24/202015
THE 1940s AND 1950s
In 1941 nearly 300 people were killed or injured
by one company’s sulfathiazole tablets, a sulfa
drug contaminated with the sedative,
Phenobarbital. That incident caused FDA to
revise manufacturing and quality control
requirements, leading to what would later be
called GMPs.

16. History of GMP & cGMP (Continued…..)
6/24/202016
•1963 GMPs for Drugs (28 FR 6385) Good
manufacturing practices for manufacturing,
processing, packing, or holding finished
pharmaceuticals were first published.
•1975 CGMPs for Blood and Blood
Components Final Rule Established minimum
current good manufacturing practices for blood
collection, processing, compatibility testing,
storage and distribution.

17. History of GMP & cGMP (Continued……)
•1976 Medical Device Amendments
Tragedy: the DalkonShield IUD seriously injures
many patients. Response: New law strengthens
FDA authority to oversee medical devices.
•1978 cGMPsfor Drugs and Devices (21
CFR 210–211 and 820)
A major rewrite for the drug GMPs and GMPs for
medical devices were published. These
regulations establish minimum current good
manufacturing practices for manufacturing,
processing, packing, or holding drug products
and medical devices.
6/24/202017

18. Importance of cGMP
GMP is important because it is related with the
well being of human life. It is developed to cure
people from illness. General people do not
understand much about drugs. So it is the
responsibility of the people involved with this
industry to produce quality and safe product and
make it available for the people.
It affects business and reputation. Some recent
incidents are mentioned on next slide.
6/24/202018

19. Importance of cGMP(continued…)
A Local GMP noncompliant incidence:
ParacetamolTragedy in Bangladesh in 1991 and
2009
Miltefosinefraud in 2008
A very recent scenario in international arena:
A British based Multinational giant Pharma has to pay $ 750
million to settle the manufacturing fraud, October, 2010.
6/24/202019

20. Importance of cGMP(continued…)
GMP is important because it affects life. Some
incidents :
•1960 : The Thalidomide case in Europe…..
Thalidomide first entered the German market in 1957 as an over-the-counter remedy, based
on the maker’s safety claims. They advertised their product as “completely safe” for
everyone, including mother and child, “even during pregnancy,” as its developers “could not
find a dose high enough to kill a rat.” By 1960, thalidomide was marketed in 46 countries,
with sales nearly matching those of aspirin.
•1970: Following the thalidomide case few
regulation were released by congress that
company has to ensure not only safety but also
the efficacy of the intended use including clinical
trial reports.
6/24/202020

21. Importance of cGMP(continued…)
•1980 & 1990: A 12 yrs old girl died after taking
Tylenol Acetaminophen capsule. Six other people
died for the same reason, 3 of them from the
same family. The mfg. company recalled 32
million bottles of the product. The investigation
revealed that, a criminal tampered had
intoxicated the bottles with Cyanide capsule.FDA
issued the tamper resistant packaging regulations
for all OTC drugs.
6/24/202021

22. Components of cGMP
6/24/202022

23. cGMP covers
6/24/202023

24. General considerations
6/24/202024

25. Personnel
6/24/202025

26. Premises
6/24/202026

27. Premises
6/24/202027

28. Premises
6/24/202028

29. Premises
6/24/202029

30. Equipments
6/24/202030

31. Sanitization
6/24/202031

32. Standard Operating Procedure
6/24/202032

33. Raw Materials
6/24/202033

34. Self Audit and Inspection
6/24/202034

35. PACKAGING & LABELING
CONTROL
6/24/202035

36. PACKAGING & LABELING
CONTROL
6/24/202036

37. WAREHOUSING AREA
(WAREHOUSE)
6/24/202037

38. 6/24/202038

39. QUALITY ASSURANCE
6/24/202039

40. Some
Examples
6/24/202040

41. Quality Control
6/24/202041

42. HVAC
6/24/202042

43. HVAC
6/24/202043

44. HVAC
6/24/202044

45. HVAC
6/24/202045

46. QA System
6/24/202046

47. Production
6/24/202047

48. Production
6/24/202048

49. Process validation
6/24/202049

50. Process Validation
6/24/202050

51. Water System
6/24/202051

52. Stabilty
6/24/202052

53. Adverse Drug Reaction
6/24/202053

54. Coding
6/24/202054

55. Coding
6/24/202055

56. Employee Training
6/24/202056

57. Ten Principles of GMP
1.Design and construct the facilities and
equipments properly
2.Follow written procedures and Instructions
3.Document work (give more paper)
4.Validate work
5.Monitor facilities and equipment
6.Write step by step operating procedures
and work on instructions
7.Design ,develop and demonstrate job
competence
8.Protect against contamination
9.Control components and product related
processes
10.Conduct planned and periodic audits
6/24/202057

58. 6/24/202058

59. Thank You