Written By: COPY TO;

STANDARD OPERATING Dr. E. Muigai

PROCEDURE NO: QA/RA Pharmacist
QA/***/X ____________________
Edition No.: X
Approved By:
PROCEDURE FOR Mr. ___________ Supersedes Edition: IX
QPPV ROLE AND Dr. _______
RESPONSIBILITIES Effective Date:
Dr. _________
Authorised By: Review Date:
Mr. N. Shrivastava
Q.A. Manager __________________

1.0 PURPOSE:
This SOP describes the role and responsibilities of the QPPV and Deputy for marketed
products at Elys Chemical Industries.
RESPONSIBILITY:
The Company Pharmacist shall be responsible for the review, update and amendments in the
Employment contract, Job description, Documentation on Qualified Person for
Pharmacovigilance and the Back Up Qualified Person for Pharmacovigilance.

No change in this SOP may be made without authority.

Introduction:
Elys Chemical Industries with medicinal products authorized for marketing in Kenya,
Uganda, Malawi, Zambia, Mozambique and Tanzania have a legal responsibility of
establishing a PV system for accomplishing PV obligations for their products. To this end,
Elys Chemical Industries must appoint an appropriately qualified person for PV (QPPV).
The role and responsibilities of the QPPV include, but are not limited to:

 Establishment and maintenance of the MAH’s PV system

 Round-the-clock (24/7) availability as the single PV point of contact for the European
Medicines Agency (EMA) and other National Competent Authorities (NCA)
 Monitoring product safety, emerging safety concerns, and risk-benefit balance of the
MAH products
 Oversight over the functioning of the PV system in all aspects, including the quality
system

Page 1 of 7
 Written By: COPY TO;
STANDARD OPERATING Dr. E. Muigai
PROCEDURE NO: QA/RA Pharmacist
QA/***/X ____________________
Edition No.: X
Approved By:
PROCEDURE FOR Mr. ___________ Supersedes Edition: IX
QPPV ROLE AND Dr. _______
RESPONSIBILITIES Effective Date:
Dr. _________
Authorised By: Review Date:
Mr. N. Shrivastava
Q.A. Manager __________________

 Access to the PV System Master File (PSMF) and ensuring that the information
contained therein is an accurate description of the PV system under the QPPV
The QPPV must be available to Elys Chemical Industries. Back-up procedures must be in
place in case of the absence of the QPPV. Where a QPPV does not reside in the country i.e.
Uganda, Malawi, Zambia, Mozambique and Tanzania, a local responsible person for PV
residing in the country must be appointed.
2.0 PROCEDURE:
2.1.1 Qualifications of a QPPV and a deputy QPPV-;
2.1.2 Shall Possess a minimum requirement of a Bachelor’s Degree in Pharmacy, with additional
certificate/diploma/fellowship or post graduate training in good pharmacovigilance practices
(GVP) from institutions recognized by Pharmacy and Poisons Board.
2.1.3 Shall in addition receive a mandatory refresher GVP trainings facilitated by the MAH (Elys
Chemical Industries) in accredited/recognized institutions by the Health Authorities. The
refresher trainings should be carried out at least once in two years and evidence of the same
submitted to PPB.
2.1.4 d. Have knowledge of applicable Health Authority guidelines (Kenya, Uganda, Tanzania,
Zambia, Malawi and Mozambique) covering safety monitoring of legislation and guidelines
plus international standards for good pharmacovigilance practices.
2.1.5 Within the first five years of acting as QPPV, in addition to the GVP training, the occupant of
this role must have completed at the least a master’s program in pharmacovigilance and
pharmacoepidemiology in institutions recognized by the board and certification provided to
the Health Authorities.
2.1.6 Demonstrate GVP knowledge in the implementation of activities stipulated in the Elys
Chemical Industries Pharmacovigilance System Master File

Page 2 of 7
 Written By: COPY TO;
STANDARD OPERATING Dr. E. Muigai
PROCEDURE NO: QA/RA Pharmacist
QA/***/X ____________________
Edition No.: X
Approved By:
PROCEDURE FOR Mr. ___________ Supersedes Edition: IX
QPPV ROLE AND Dr. _______
RESPONSIBILITIES Effective Date:
Dr. _________
Authorised By: Review Date:
Mr. N. Shrivastava
Q.A. Manager __________________

2.1.7 Shall have current/valid practice license from Pharmacy and Poisons Board as the QPPV
pharmacist and must be prominently displayed at Elys Chemical Industries premises.
2.1.8 h. Shall be qualified by pertinent training or experience relevant to their assigned
responsibilities.
2.1.9 Roles and responsibilities of a QPPV and a deputy QPPV-;
2.1.10 The establishment and maintenance of the marketing authorization holder's
pharmacovigilance system master file and therefore should have sufficient authority to
influence the performance of the quality system and the good pharmacovigilance standards
and to promote, maintain and improve compliance with the legal requirements. Hence, the
QPPV should have access to the pharmacovigilance system master file (PSMF) at all
times.
2.1.11 Having oversight over the functioning of the pharmacovigilance system in all relevant
aspects including quality management system (e.g. standard operating procedures,
contractual arrangements, database operations, compliance data regarding quality,
completeness and timeliness of expedited reporting and submission of periodic update
reports, audit reports and training of personnel in relation to pharmacovigilance).
2.1.12 The QPPV shall act as a single point of contact for the Board on all matters relating to the
product safety and quality of their marketed products including pharmacovigilance
inspections.
2.1.13 Preparing, reviewing and implementing company SOPs for PV activities.
2.1.14 The QPPV should be aware of the validation status of the adverse reaction database if
applicable, including any failures that occurred during validation and the corrective actions
that have been taken to address the failures. The QPPV should also be informed of
significant changes that are made to the database (e.g. changes that could have an impact on
pharmacovigilance activities).

Page 3 of 7
 Written By: COPY TO;
STANDARD OPERATING Dr. E. Muigai
PROCEDURE NO: QA/RA Pharmacist
QA/***/X ____________________
Edition No.: X
Approved By:
PROCEDURE FOR Mr. ___________ Supersedes Edition: IX
QPPV ROLE AND Dr. _______
RESPONSIBILITIES Effective Date:
Dr. _________
Authorised By: Review Date:
Mr. N. Shrivastava
Q.A. Manager __________________

2.1.15 The QPPV may delegate specific tasks, under supervision, to appropriately qualified and
trained individuals, for example, acting as safety experts for certain products, provided that
the QPPV maintains system oversight and overview of the safety profiles of all products.
Such delegation should be documented.
2.1.16 Establishing and maintaining a system which ensures that information about all suspected
adverse drug reactions/events (or spontaneous post marketing events) which are reported to
the personnel of the marketing authorization holder, including to medical representatives, is
collected, collated, processed and evaluated and forwarded to the Board in line with the
timelines stipulated by the Board.
2.1.17 Preparing and submitting the following to the Board through established channels:
2.1..1 Adverse Events to Medical Products and Health Technologies
2.1..2 Periodic Safety Update Reports and Periodic Benefit-Risk Evaluation
2.1..3 Reports (PSUR/PBRER)
2.1..4 Company-sponsored pre- and post-registration study reports
2.1..5 Risk Management Plans (RMPs)
2.1..6 Ongoing pharmacovigilance evaluation during the post-registration
period.
2.1.17.1 The report should be submitted to PPB as soon as possible after the
evaluation.
2.1.18 Ensuring that any request from the Board for additional information deemed necessary for
the evaluation of the risk-benefit ratio of a marketed product, is provided to the Board fully
and promptly.
2.1.19 Overseeing the safety profiles of the company’s marketed products and any emerging safety
concerns.

Page 4 of 7
 Written By: COPY TO;
STANDARD OPERATING Dr. E. Muigai
PROCEDURE NO: QA/RA Pharmacist
QA/***/X ____________________
Edition No.: X
Approved By:
PROCEDURE FOR Mr. ___________ Supersedes Edition: IX
QPPV ROLE AND Dr. _______
RESPONSIBILITIES Effective Date:
Dr. _________
Authorised By: Review Date:
Mr. N. Shrivastava
Q.A. Manager __________________

2.1.20 Ensuring that all personnel involved in pharmacovigilance activities, which may include
customer service and sales representatives etc. have their specific duties recorded in a
written description and have adequate authority to carry out their responsibilities.
2.1.21 Ensuring that all personnel involved in pharmacovigilance activities should be aware of the
principles of pharmacovigilance that affect them, and all personnel shall receive relevant
training.
2.1.22 Ensuring that competent persons are appointed to carry out their duties and functions in their
absence.
2.1.23 Ensuring that Qualified health care professional possessing adequate experience and
education (e.g. QPPV and medical affairs staff), should be available to evaluate information
in respect of potential ADEs, assesses the seriousness, expectedness and reportability of
ADEs and determine if the ADE report qualifies for expedited reporting.
2.1.24 Ensuring that training is provided prior to implementation of new or revised procedures.
Records of training should be maintained.
2.1.25 Have an oversight of the PMS activities of the MAHs products registered in the country.
2.1.26 Annual Review of the role and responsibilities of the QPPV and deputy QPPV
2.1.27 The roles and responsibilities of the QPPV and Deputy QPPV shall be conducted by the
company pharmacist during the month of January to ensure the roles and responsibilities are
up to date as per available health authority pharmacovigilance guidelines and legislations.
2.1.28 The Company Pharmacist shall ensure that the QPPV and Deputy QPPV have conducted an
annual refresher training the through Uppsala Monitoring Centre website training modules
for pharmacovigilance (https://learning.who-umc.org/home) as part of the health authority
requirement.
2.1.29 The Company Pharmacist shall also ensure that all regulatory licences have been renewed,
up to date and are valid.

Page 5 of 7
 Written By: COPY TO;
STANDARD OPERATING Dr. E. Muigai
PROCEDURE NO: QA/RA Pharmacist
QA/***/X ____________________
Edition No.: X
Approved By:
PROCEDURE FOR Mr. ___________
Supersedes Edition: IX
QPPV ROLE AND Dr. _______
RESPONSIBILITIES Effective Date:
Dr. _________
Authorised By: Review Date:
Mr. N. Shrivastava
Q.A. Manager __________________

2.1.30 The Company pharmacist shall ensure that all Local Technical Representative have an
appointed local QPPV and all regulatory requirements have been fulfilled as per applicable
local regulation and Safety Data Exchange Agreement/QPPV agreement.

3.0 ANNEXURE:

ANNEXURE
TITLE OF THE ANNEXURES FORM NO.
NO.
Annexure I New Employee Induction Form

4.0 ABBREVIATIONS:

SR.NO. ABBREVIATIONS FULL FORM

01 QPPV Qualified Person for Pharmacovigilance

07 AEPQC Adverse Events Product Quality Complaints
08 CCDS Company Core Data Sheet

Page 6 of 7
 Written By: COPY TO;
STANDARD OPERATING Dr. E. Muigai
PROCEDURE NO: QA/RA Pharmacist
QA/***/X ____________________
Edition No.: X
Approved By:
PROCEDURE FOR Mr. ___________
Supersedes Edition: IX
QPPV ROLE AND Dr. _______
RESPONSIBILITIES Effective Date:
Dr. _________
Authorised By: Review Date:
Mr. N. Shrivastava
Q.A. Manager __________________

5.0 REVISION HISTORY:

EDITION EFFECTIVE
REVISION SUMMARY
NO. DATES

I Need for an SOP was realised.

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