1. GMP & Quality AssuranceB

2. Introduction
GMP ensures that quality is built into the organization & processes involved in manufacture
GMP covers all aspects of manufacture including collection, transportation, processing, storage, QC & delivery of the finished product

3. GMP
Part of QA which ensures that products are consistently produced & controlled to the quality standards appropriate to their use.
GMP is an integral part of QA.

4. QA, GMP & QC inter-relationship
It 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

5. QA, GMP & QC inter-relationship
Is that part of QA aimed at ensuring that products are consistently manufactured to a quality appropriate to their intended use

6. QA, GMP & QC inter-relationship
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

7. QC & QA Part of GMP which is concerned with sampling,
specifications, testing and with in the organization, documentation and release procedures which ensure that the necessary & relevant tests are carried out
QA is the sum total of organized arrangements made with the object of ensuring that product will be of the Quality required by their intended use.

8. QC & QA
Operational laboratory techniques & activities used to fulfill the requirement of Quality
All those planned or systematic actions necessary to provide adequate confidence that a product will satisfy the requirements for quality

9. QC & QA
QC is laboratory
based
QA is company
based

10. GMP GMP in solid dosage forms GMP in semisolid dosage forms
GMP in Liquid orals
GMP in Parenterals Production
GMP in Ayurvedic medicines
GMP in Biotechnological products
GMP in Nutraceuticals & cosmeceuticals
GMP in Homeopathic medicines

11. GMP Good Manufacturing Practice Good Management Practice
Get More Profit
Give more Production
GMP Training with out tears

12. Ten Principles of GMP
Design & construct the facilities & equipments properly
Follow written procedures & Instructions
Document work
Validate work
Monitor facilities & equipment
Write step by step operating procedures & work on instructions
Design, develop & demonstrate job competence
Protect against contamination
Control components & product related processes
Conduct planned & periodic audits

13. Beyond GMP Reduce pollution - Zero discharge
Adaptation of environment friendly methods
Consideration for better & healthier life tomorrow
Consideration of ethics in life
One should begin with end in mind otherwise it will be the beginning of the end

14. Cost of effective GMP
In fact Cost benefits – positive cost benefits of GMP/QA
Good plant lay out, Smooth work flows, Efficient documentation systems, well controlled process, good stores lay outs and stores records- These are Good manufacturing practices
Reduction in work in process & inventory holding costs
Avoidance of cost of Quality failure ( cost of waste, of rework, of recall, of consumer compensation and of loss of company reputation)

15. List of important documents in GMP
Policies
SOP
Specifications
MFR (Master Formula Record)
BMR
Manuals
Master plans/ files
Validation protocols
Forms & Formats
Records

16. How do GMPs of different countries compare?
At a high level, GMPs of various nations are very similar; most require things like:
Equipment & facilities being properly
designed, maintained, & cleaned
SOPs be written & approved
An independent Quality unit (like QC and/or QA)
Well trained personnel & management

17. Basic Requirements of GMP
All manufacturing processes are clearly defined, systematically reviewed, & shown to be capable of consistently manufacturing medicinal products of the required quality & complying with specifications.
Critical steps of the process and significant changes to the process are validated

18. Why GMP is important
A poor quality medicine may contain toxic substances that have been unintentionally added.
A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect.

19. Quality Management

20. QUALITY RELATIONSHIP Quality Management Quality Assurance G.M.P.QA
GMP
Quality Assurance QC
G.M.P.
Quality Control

21. What is Quality Management?
The aspect of management function that determines & implements the “quality policy”
The overall intention & direction regarding quality, as formally expressed & authorized by top management

22. BASIC PRINCIPLE OF QUALITY MANAGEMENT (1)
Manufacturer should ensure the cosmetic products comply with the requirements of ASEAN Cosmetic Directives (ACD).
They should also comply with any other applicable regulations pertaining to your specific country.
The attainment of this quality objective should be led by the senior management & requires the participation and commitment by staff, by the company’s suppliers and distributors.

23. BASIC PRINCIPLE OF QUALITY MANAGEMENT (2)
To achieve the reliable quality objective, there should be a comprehensive QA system incorporating GMP.
The QA system should be fully documented & its effectiveness should be monitored.

24. QUALITY ASSURANCE
QA covers all matters which individually or collectively influence the quality of a product.
All parts of QA system should be adequately resourced with:
Competent personnel
Suitable & sufficient premises, equipment & facilities

25. Principles of Quality Assurance (QA)
Wide-ranging concept
Covers all matters that individually or collectively influence the quality of a product
Totality of the arrangements
To ensure that the drug is of the right quality for the intended use
QA incorporates GMP
and also product design &
development which is outside the
scope of this module

26. BASIC REQUIREMENTS OF QA
Ensure that products are designed and developed based on sound scientific rationale and with GMP or GLP principles being taken into consideration.
Ensure that managerial responsibilities are clearly specified.
Ensure that production and control operations are clearly specified and GMP is adopted.
Organize supply & use of correct starting & packaging materials.
Ensure that finished products are correctly processed & checked before release.
Ensure that products are released after review by authorized person.
Provide satisfactory arrangement to ensure products are stored, distributed & handled appropriately.
Put in place a mechanism for regular self inspection / internal quality audit.

27. GOOD MANUFACURING PRACTICES
Part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use.
Minimize risks :
cross contamination
mix up
Ensure products/materials are traceable to the original source.
Product testing is not reliable way to assure product quality. Should BUILD quality into the product!
Production and quality control functions should be independent of each other.
All manufacturing process are clearly defined and systematically reviewed.

28. All necessary facilities/resources for GMP should be provided :
adequate, qualified and well-trained personnel
suitable premises and sufficient space
suitable location
good personal hygiene and proper sanitation
suitable equipment and services

29. QUALITY CONTROL QC is part of GMP.
QC is concerned with sampling, specification and testing.
Manufacturer should have a QC department.
QC should be headed by an appropriately qualified and experienced person.
QC should be independent from production and other departments.
Ensure that the necessary and relevant tests are actually carried out.
Ensure that no materials or products will be released for sale or supply, until their quality have been evaluated and judged to be satisfactory.

30. SCOPE OF QC Items concerned : Starting materials Packaging materials
Bulk products
Intermediate and finished products
Environmental conditions

31. BASIC REQUIREMENTS OF QUALITY CONTROL (1)
Adequate facilities, trained personnel and approved procedures should be available for sampling,
inspecting and testing and, where appropriate, environment monitoring.
Sampling by QC personnel & testing by approved
methods.
Approved test methods.
Maintenance of QC records &
failure investigation records.

32. BASIC REQUIREMENTS OF QUALITY CONTROL (2)
Ingredients comply with regulatory specification (grade, composition, strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials and finished products

33. OTHER DUTIES OF QC
Establish QC procedures
Manage reference standards
Ensure correct labeling
Stability testing (if applicable)
Complaint investigation
Environmental monitoring

34. QUALITY CONTROL ACTIVITIES
QC should cover the following:
Sampling
Specification
Testing
Release procedures
Recalls and complaints
Decision making in all quality matters
Definition of product quality
Laboratory operations
Release authorisation
Investigation and reporting

35. BASIC REQUIREMENTS OF QUALITY CONTROL
Adequate facilities, trained personnel and approved procedures should be available for sampling, inspecting and testing and, where appropriate, environment monitoring.
Sampling by QC personnel & testing by approved methods.
Approved test methods.
Maintenance of QC records & failure investigation records.
Ingredients comply with regulatory specification (grade, composition, strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials and finished products

36. OTHER DUTIES OF QC Establish QC procedures Manage reference standards
Ensure correct labeling
Stability testing (if applicable)
Complaint investigation
Environmental monitoring

37. Personnel

38. PERSONNEL
Adequate staff with relevant knowledge, experience and capabilities in assigned task
a. Production and QC are headed by different persons, neither of whom shall be responsible to the other
b. Responsibilities and authority of key personnel are clearly defined
c. Training on the understanding of procedures, work instruction, GMP principles , etc.

39. Personnel Qualifications
“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 ...”

40. There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision.
􀁺 The responsibilities of all staff should be clearly understood and recorded.
􀁺 All personnel receive initial and continuing training relevant to their needs.
􀁺 Only staff who have appropriate training are authorised to carry out that procedure.
􀁺 Training should be structured and continuous. Training records based on SOPs are a good means of evidencing that staff are able to perform tasks.
􀁺 Competency Assessments can also be used to assess procedural training.

41. 3 Key Personnel The head of production The head of QC
The head of QM (QA)

42. The head of production
The head of production should be a qualified pharmacist, adequately trained, possess good practical experience in pharmaceutical manufacture & managerial skill.
The head of production should have full authority & responsibility to manage production of pharmaceutical products.

43. The head of QC
The head of QC should be a qualified pharmacist, have adequate training & practical experiences which enable him/her to perform him/her function personally.
The head of QC should given full authority & responsibility in all QC duties.

44. The head of QM (QA)
The head of QM (QA) should be a qualified pharmacist, have adequate training & practical experiences which enable him/her to perform him/her function personally.
The head of QM (QA) should given full authority & responsibility in all quality system/assurance duties.

45. Premises

46. PREMISES
Specify the requirements of location, design , constructions and maintenance of manufacturing premises with respect to the following:
prevention of contamination from surrounding environment and pests
prevention of mix up of materials and products
facilities such as toilet, changing rooms, sampling areas and QC lab
defined areas for certain activities
wall, ceiling, drains , air intake and exhaust, lighting and ventilation, pipe work and light fitting
storage areas

47. Suitable location, design , constructions and maintenance for manufacturing premises :
defined areas for certain activities (e.g material sampling & dispensing)
wall, ceiling, drains , air intake and exhaust, lighting and ventilation, pipe work and light fitting
storage areas of adequate space
Physical separation of toilets and QC lab from production

48. Building & facilities Design and construction features. Lighting.
Ventilation, air filtration, air heating and cooling.
Plumbing.
Sewage and refuse.
Washing and toilet facilities.
Sanitation.
Maintenance.

49. Paint Finish…
Not only building paintwork must be considered but also equipment

50. Building Finishes:
In module 1 we discussed the need for all facility components to complement each other.
Therefore a good air handling system must be complemented by a building of good design and good finishes.
On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes.

51. Building Finishes Not Acceptable Acceptable J PVA Paint L
Epoxy or Enamel paint J
Window sills
Flush glazed windows
Exposed pipes
Smooth surfaces
Horizontal pipes & services
Concealed services
Open floor drains
Hygienic drains
Floor cracks, flaking floor surfaces
Homogonous sealed floors – epoxy finish or welded vinyl
Ceiling cracks & joints
Smooth sealed ceilings
Exposed, open light fittings
Flush light fittings
Wooden furniture
S/Steel or Melamine furniture

52. Floors / drains

53. Design and Construction Features
“Any building or buildings used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction, and location to facilitate cleaning, maintenance, and proper operation.”

54. Product Areas 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, the requisite cleanliness levels,
To avoid crowding and disorder,
To allow effective communication and supervision.

55. Weighing Area
The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use. Such areas may be part of either storage or production areas.

56. Storage Areas
Specify the requirements concerning storage of materials/ products with respect to the following
Space, design, security and cleanliness
Storage of quarantine stocks
Storage of hazardous substances
Conditions of storage area
(e.g. temperature & relative humidity)
Receiving of incoming materials
Stock control (e.g. FIFO principle,
proper labeling on the container)

57. Ventilation, Air Filtration, Air Heating and Cooling
“Equipment for adequate control over air pressure, micro-organisms, dust, humidity, and temperature shall be provided when appropriate for the manufacture, processing, packing, or holding of a drug product.”
“Air-handling systems for ... penicillin shall be completely separate from those for other drug products for human use.”

58. Poor & Good Windows

59. QC Areas
QC laboratories should be designed to suit the operations to be carried out in them.
QC laboratories should be separated from production areas.
Areas where biological or radioisotope test methods are employed should be separated from each other.

60. Ancillary Areas
Rest and refreshment rooms should be separated from production & QC laboratory areas.
Facilities for changing clothes and for washing and toilet purposes should be easily accessible & appropriate for the number of users.

61. Thank you
for
Your Kind
Attention