Pharmaceutical Quality Assurance B.Pharmacy Third Year Sem-VI As per PCI Syllabus

1. Prepared By:- Ms. Mali Sunayana M.
Asst. Professor
Subject:- Pharmaceutical Quality Assurance
Sahyadri College Of Pharmacy, Methwade, Sangola.
UNIT-II CHAPTER-7

2.  Upon completion of this section, the student
should be able to:
 List out the responsibilities of key personnel in
a pharmaceutical manufacturing unit.
 Describe functions of the Quality Control (QC)
unit.
 Explain the education, training and other
requirements for personnel in the
organization.
 Outline the health and hygiene requirements
for personnel.

3.  In the complex field of pharmaceutical
manufacturing, it is important to have a sound
quality system in place to make sure that products
manufactured have the desired quality, safety and
efficacy.
 At the same time, it is vital to recognize that even
the best quality system is only as good as the
people who make it work. Personnel are the
backbone of the manufacturing unit, and there must
be a sufficient number of adequately qualified and
trained staff to ensure one achieves the desired
quality products.
 No person should be so burdened with
responsibilities that it presents a quality risk.

4.  Sufficient number of personnel must be present to
perform as well as to supervise the manufacture,
processing, packing and holding of every drug
product.
 In any pharma unit it is important to lay out
individual responsibilities in a manner that is clear
enough to be understood by the personnel who
are to perform the respective tasks.
 Written job descriptions must be available and an
organization chart must be prepared to show the
hierarchical organization of employees.

6. Production Head
responsibilities
Quality Control Head
responsibilities
Shared responsibilities
Production and storage of
products as per
requirements
Approval or rejection of
starting materials,
intermediate and finished
products and packaging
materials
Monitoring and approval of
material suppliers and
contract manufacturers.
Approval of instructions for
processing operations.
Evaluation of batch records. Monitoring and control of
environment in the
production areas.
Evaluation and singing of
production records
Approval of specifications,
test methods, sampling
methods and other QC
procedures
Ensuring validations are
carried out.
Verification of maintenance
of premises, equipment and
manufacturing and packing
areas
Ensuring testing is
performed as per protocols
Training of personnel
Ensure periodic personnel
training is performed.
Monitoring and approval of
contract analysis
Monitoring compliance with
cGMPs

7.  Every pharmaceutical manufacturing unit should have a
quality control unit. There must be written procedures to
describe the functioning and responsibilities of this unit, and
these procedures must be followed.
 The QC unit has the responsibility of testing all raw
materials, drug products, containers, closures, in-process
materials, labeling and packaging material. It also has the
authority to accordingly approve the materials that meet
quality, safety and efficacy specifications and reject the
ones that do not meet them.

8.  The QC unit also has the authority to review the
records generated during production of every
batch to ensure that errors have not occurred at
any stage or that any errors that occurred have
been completely investigated.
 In case a company A gets products
manufactured under contract by another
company B, the QC unit of A has the authority to
approve or reject those products manufactured,
packed, processed or held by B for A.

9.  All persons involved with the manufacture,
processing, packing or holding of drug products
must wear clothing that is clean and suitable for
the work to be performed. Wherever required,
personnel must wear adequate protective apparel
to cover their face hands, arms, head etc to
prevent contamination of the drug product.
 Personnel must practice good health and
sanitation habits. T hey 'must enter only those
areas of the premises that they have been
authorized to enter. Limited access areas can be
entered only after due authorization by the
supervisory persons.

10.  All persons engaged in the manufacturing,
processing, packing or holding of drug
products must have the necessary education,
training and experience, or an acceptable
combination of these to ensure they are
capable of carrying out the assigned work.
 Personnel must be trained on the particular
operations they perform and on the current
Good Manufacturing Practices (cGMP) that
are relevant to their area of work.

11.  cGMP training must be imparted on a regular basis
by adequately qualified trainers to ensure the
employees stay current in their information about
the relevant cGMP requirements.
 Every person who supervises the manufacture,
processing, packing or holding of drug products
must have the necessary education, training and
experience, or an acceptable combination of these
to ensure they are capable of carrying out the
assigned supervisory work.

12.  Key positions must be held by full-time personnel.
This generally includes the heads of production
and quality control and the authorized person.
 The heads of quality control and production must
be independent of each other and they bear the
responsibility of all actions performed by their
subordinates.
 The key personnel must have sufficient scientific
education and practical experience in the
manufacture of drug products in keeping with
national regulatory guidelines.

13.  They must be capable of making independent
judgment based on applying scientific thought
to the problems that may be encountered
white performing their responsibilities.
 The authorized person is responsible to
implement the quality system, perform internal
audit or self inspection, and participate in
validation programs.
 This person is ultimately held accountable for
any non-compliance with regulatory
requirement.

14.  All personnel entering the manufacturing areas and
quality control laboratories (including housekeeping
staff) must be trained according to a written program.
 The training Programs must cover technical aspects of
their work. and also the theory and practice of cGMP.
 Personnel working in clean areas or areas where
hazardous materials are being handled must be
imparted specific training on the precautions they must
follow to avoid contaminating the product or the
environment and also for personal safety.
 Training must be done at regular intervals and the
effectiveness of the training must be assessed.
Records of personnel training must be maintained.

15.  Personnel to be employed in a drug product
manufacturing facility must undergo health
examination before being hired.
 Only those who are free from contagious,
communicable conditions, skin diseases and
tuberculosis must be given employment.
 Persons to be employed in an area where
beta lactam antibiotics are being
manufactured must be tested for sensitivity to
penicillin before being employed.

16.  Those employees who need to perform visual
inspections must have periodic eye checkups.
 Personnel handling cytotoxic drugs, sex
hormones and other potent medicaments
must be examined regularly for any adverse
effect of these substances.
 As a safety measure, it is good to rotate staff
in these special areas.

17.  Personnel must be trained in personal
hygiene aspects such as washing their hands
donning appropriate protective clothing, using
a face mask and hair cap etc before entering
manufacturing areas.
 Change rooms must be provided with facilities
for storing personal belongings, and ensuring
personal hygiene (wash basins, running
water, hand dryers disinfectants etc).
 Employees must be instructed about not
allowing direct contact between their hands
and any raw material, in-process goods or
finished, unpacked drug product.

18.  If any person is found to have an open lesion or
an illness (by observation of the supervisor or
through a medical examination) that may have an
impact on the quality or safety of drug products,
that person must be kept away from coming into
direct contact with drug product, containers and
closures and in-process materials until declared fit
to do so by a medical professional.
 A team of skilled and trained personnel is one of
the biggest factors that influence the production of
quality products that are safe and efficacious.

19. 1. Explain the division of responsibilities
between the Production and QC Heads in a
pharma company.
2. Describe the types of training that must be
given to personnel in a pharmaceutical' unit.
3. What precautions must be taken from the
health and hygiene point of personnel?

20. 20
PROF. MALI SUNAYANA
1) A Text book of Pharmaceutical Quality Assurance by the author
Anusuya R.Kashi, Bindu Sukumaran, And Veena P. Nirali
Prakashan. Page No.7.1-7.4
2) www.slideshare.com
3) www.google.com