JICKSTAR PHARMA INC.

STANDARD OPERATING PROCEDURE

“Confidential and Proprietary”
Department: Section:
QUALITY ASSURANCE
Title: Code:
SELF-INSPECTION CHECKLIST SOP-QA-04.03
Chapter 2 - PERSONNEL
Supersedes: Issue No.: Review Date: Page:
SOP-QA-04.02 03 NOV 2020 1 of 3

Audited by : Date of Audit:

Method of Evaluation
Chapter SCOPE DR: Documentation Review
OSE: On-site Evaluation
DR OSE YES NO REMARKS
GENERAL
2.1 Is there an adequate number of personnel
with necessary qualifications and practical X X
experience?
Is the senior management provide adequate X X
and appropriate resources?
Is Pharmaceutical Quality System and X X
continuing improve implement and
maintain?
 responsibilities placed on any one
individual should not be so X X
extensive as to present any risk to
quality.
2.2 Is there an organizational chart available? X X
Is there a written job description for people X X
in responsible positions?

2.3 Does the people in responsible position X X

have their specific duties?
Is there a written job description for people
in responsible positions?
 Duties may delegated to designated X X
deputies of a satisfactory
qualification level.
 There should be no gaps or X X
unexplained overlaps in the
responsibilities of those personnel
concerned with the application of
GMP.
2.4 Is the key personnel responsible to ensure X X
an Effective Pharmaceutical Quality
System?
 To achieve the quality objectives, X
and, the roles, responsibilities, and
authorities are defined,
communicated and implemented
throughout the organization.
Prepared By: Reviewed By: Approved By:

LIEZL ANN T. ASLARONA JESSEL PERSIA T. CARBONELL NIDA T. GALLEGO

Date: Date: Date:
 JICKSTAR PHARMA INC.
STANDARD OPERATING PROCEDURES
“Confidential and Proprietary”
Department: Section:
QUALITY ASSURANCE
Code:
Title: SOP-QA-04.03
SELF-INSPECTION CHECKLIST
Page:
Chapter 2 - PERSONNEL 2 of 6

2.6 Is the duties of the Authorized Person are

described in the national requirements?
 Does the authorized Person must X
ensure each batch of medical
products has been manufacture and
check in compliance with the laws?
 Does the authorized Person must X
meet the qualification requirements
laid down in the national legislation?
 Does the responsibilities of an X
Authorized Person may be delegated,
but only to other Authorized Person?
2.7 Does the Head of Production Department
carries the following responsibilities?
 Ensures that products are produced X
according to the appropriate
documentation in order to obtain the
required quality.
 Approves the instructions relating to X
production operations and ensures
their strict implementation.
 Are the key personnel establishing X X
a quality policy?
 It describes the overall intentions X
and directions of the company.
 Ensure continuing suitability and X X
effectiveness of the Pharmaceutical
Quality System and GMP
compliance through participation in
management review.
KEY
PERSONNE
L
2.5 Are key personnel Head of Production, X X
Head of Quality Control responsible for the
release of products?
 Is there an authorized person for the X
release of product? X
 Are the key posts occupied by full- X X
time personnel?
 Are the Head of Production and X X
Quality Control independent from
each other?
 JICKSTAR PHARMA INC.
STANDARD OPERATING PROCEDURES
“Confidential and Proprietary”
Department: Section:
QUALITY ASSURANCE
Code:
Title: SOP-QA-04.03
SELF-INSPECTION CHECKLIST
Page:
Chapter 2 - PERSONNEL 3 of 6

 Ensures that the production records X

are evaluated and signed by an
authorized person before they are sent
to the Quality Control Department.

Checks the maintenance of his X

department, premises and equipment..
 Ensures that the appropriate X
validations are done.
 Ensures that the required initial and X
continuing training of his department
personnel is carried out and adapted
according to need.
2.8 Does the Head of Quality Control Department
have the following responsibilities?

Approves or rejects, as he sees fit, X

starting materials, packaging materials
and intermediate, bulk and finished
products.
 Evaluates batch records. X
 Ensures that all necessary testing is X
carried out
 Approves specifications, sampling X
instructions, test methods and other
Quality Control procedures.
 Approves and monitors any contract X
analysts.
 Checks the maintenance of his X
department, premises and equipment.
 Ensures that the appropriate X
validations are done.
 Ensures that the required initial and X
continuing training of his department
personnel is carried out and adapted
according to need
2.9 Does the Head of Quality Control Department X X
have the following shared or jointly exercised
responsibilities relating to quality?
 Authorization of written procedures X
and other documents, including
amendments.
 Monitoring and control of X
manufacturing environment.
 Plant hygiene. X
 Process validation X
 JICKSTAR PHARMA INC.
STANDARD OPERATING PROCEDURES
“Confidential and Proprietary”
Department: Section:
QUALITY ASSURANCE
Code:
Title: SOP-QA-04.03
SELF-INSPECTION CHECKLIST
Page:
Chapter 2 - PERSONNEL 4 of 6

 Training. X
 Approval and monitoring of suppliers of X
materials.
 Approval and monitoring of contract X
manufacturers.
 Designation and monitoring of storage X
conditions for materials and products.
 Retention of records. X
 Monitoring of compliance with the X
requirements of GMP.
 Inspection, investigation, and taking of X
samples, in order to monitor factors,
which may affect product quality.
TRAIN
ING
2.10 Does the training on basic Good Manufacturing X
Practice is provided for all personnel whose
duties take them into production areas or
control laboratories?
Is it provided for other personnel whose X
activities could affect the quality of the
product?

2.11 Do the newly recruited personnel receive X

trainings appropriate to the duties assigned to
them?

Does the training given continiously? X

2.12 Are there specific trainings given to personnel X X
working in clean areas or areas where highly
active or toxic materials are handled?
2.13  Are the visitors or untrained personnel X X
taken into the production and Quality
Control areas given information in
advance, about personal hygiene and
prescribed protective clothing?
 Are they closely supervised? X X
2.14 Is the concept of Quality Assurance and all the X X
measures capable of improving its
understanding and implementation fully
discussed during training sessions?
PERSONNEL HYGIENE
2.15 Is there detailed hygiene programmes X X
established and adapted to the different needs
within the factory?
 Includes procedure relating to the X
health, hygiene practices and clothing
of personnel.
 JICKSTAR PHARMA INC.
STANDARD OPERATING PROCEDURES
“Confidential and Proprietary”
Department: Section:
QUALITY ASSURANCE
Code:
Title: SOP-QA-04.03
SELF-INSPECTION CHECKLIST
Page:
Chapter 2 - PERSONNEL 5 of 6

Does the procedures followed and understood X X

in a very strict way by every person whose
duties take him into the production and control
areas?
Is the hygiene programmes widely discuss X X
during training sessions?
2.16 Do all personnel submit their selves for medical X
examination upon recruitment?
 Manufacturer’s responsibility that there X
are instructions ensuring that health
conditions that can be relevance to the
quality of product.
 After the first medical examination, it X
should be carried out when necessary
for the work and personal health.
2.17 Are there steps be taken to ensure that no X X
person affected by an infectious disease or
having open lesions on the exposed surface of
the body is engaged in the manufacture of
medicinal products?
2.18 Is every person entering the manufacturing x X
areas wear protective garments appropriate to
the operation?
2.19 Does eating, drinking, chewing, or the storage x X
of food, drink, smoking materials or personal
medication are prohibited in the production and
storage areas?
 In general, any unhygienic practice X
within the manufacturing area or in any
other area where the product might be
adversely affected should be
forbidden.
2.20 Does the machine operator has a direct X
contact to the exposed product?
2.21 Is the personnel use hand-washing facilities? X
2.22 Do the specific requirements are covered in the X
annexes?
2.23 Are the consultants shows proper education, X X
training, and experience or any combination
thereof to advise on the subject for which they
are retained?
 JICKSTAR PHARMA INC.
STANDARD OPERATING PROCEDURES
“Confidential and Proprietary”
Department: Section:
QUALITY ASSURANCE
Code:
Title: SOP-QA-04.03
SELF-INSPECTION CHECKLIST
Page:
Chapter 2 - PERSONNEL 6 of 6

END OF DOCUMENT