GMP & Quality

Assurance
B
 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
 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.
QA, GMP & QC inter-
relationship
QA
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
 QA, GMP & QC inter-
relationship
GMP
Is that part of QA aimed at ensuring
that products are consistently
manufactured to a quality
appropriate to their intended use
 QA, GMP & QC inter-
relationship
QC
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
 QC & QA
• Part of GMP which is • QA is the sum total of
concerned with organized
sampling, arrangements made
specifications, with the object of
testing and with in the ensuring that product
organization, will be of the Quality
documentation and required by their
release procedures intended use.
which ensure that the
necessary & relevant
tests are carried out
 QC & QA
• Operational • All those planned
laboratory or systematic
techniques & actions necessary
activities used to to provide
fulfill the adequate
requirement of confidence that a
Quality product will satisfy
the requirements
for quality
 QC & QA

QC is laboratory QA is company
based based
 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
 GMP
• Good Manufacturing Practice
• Good Management Practice
• Get More Profit
• Give more Production
• GMP Training with out tears
 Ten Principles of GMP
1. Design & construct the facilities & equipments
properly
2. Follow written procedures & Instructions
3. Document work
4. Validate work
5. Monitor facilities & equipment
6. Write step by step operating procedures & work on
instructions
7. Design, develop & demonstrate job competence
8. Protect against contamination
9. Control components & product related processes
10. Conduct planned & periodic audits
 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
 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)
 List of important documents in
GMP
• Policies
• SOP
• Specifications
• MFR (Master Formula Record)
• BMR
• Manuals
• Master plans/ files
• Validation protocols
• Forms & Formats
• Records
 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
 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
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.
 QUALITY
RELATIONSHIP
Quality Management
QA

GMP
Quality Assurance
QC
G.M.P.

Quality Control
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
 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.
 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.
 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
 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
 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.
 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.
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
 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.
 SCOPE OF QC

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

Establish QC procedures
Manage reference standards
Ensure correct labeling
Stability testing (if applicable)
Complaint investigation
Environmental monitoring
 QUALITY CONTROL
ACTIVITIES

QC should cover the following:

a. Sampling
b. Specification
c. Testing
d. Release procedures
e. Recalls and complaints
f. Decision making in all quality matters
g. Definition of product quality
h. Laboratory operations
i. Release authorisation
j. Investigation and reporting
 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
 OTHER DUTIES OF QC

Establish QC procedures
Manage reference standards
Ensure correct labeling
Stability testing (if applicable)
Complaint investigation
Environmental monitoring
 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.
 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 ...”
• 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.
 3 Key Personnel
• The head of production
• The head of QC
• The head of QM (QA)
 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.
 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.
 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.
 PREMISES
Specify the requirements of location, design ,
constructions and maintenance of manufacturing
premises with respect to the following:
a. prevention of contamination from surrounding
environment and pests
b. prevention of mix up of materials and products
c. facilities such as toilet, changing rooms, sampling
areas and QC lab
d. defined areas for certain activities
e. wall, ceiling, drains , air intake and exhaust,
lighting and ventilation, pipe work and light
fitting
f. storage areas
• 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
 Building & facilities
1. Design and construction features.
2. Lighting.
3. Ventilation, air filtration, air heating and
cooling.
4. Plumbing.
5. Sewage and refuse.
6. Washing and toilet facilities.
7. Sanitation.
8. Maintenance.
Paint Finish…
• Not only building
paintwork must be
considered but also
equipment
 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.
 Building Finishes
Not Acceptable Acceptable
PVA Paint  Epoxy or Enamel 
paint
Window sills  Flush glazed windows 
Exposed pipes  Smooth surfaces 
Horizontal pipes &  Concealed services 
services
Open floor drains  Hygienic drains 
Floor cracks, flaking  Homogonous sealed
floor surfaces floors – epoxy finish 
or welded vinyl
Ceiling cracks &  Smooth sealed 
joints ceilings
Exposed, open light  Flush light fittings 
fittings
Wooden furniture  S/Steel or Melamine 
furniture
Floors / drains
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.”
 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.
 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.
 Storage Areas

Specify the requirements concerning storage of

materials/ products with respect to the
following
a. Space, design, security and cleanliness
b. Storage of quarantine stocks
c. Storage of hazardous substances
d. Conditions of storage area
e. (e.g. temperature & relative humidity)
f. Receiving of incoming materials
g. Stock control (e.g. FIFO principle,
h. proper labeling on the container)
 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.”
Poor & Good Windows
 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.
 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.
Thank you
for
Your Kind
Attention