Page 8 - PPTL.QM.001 Iss 01 - ISO 9001 Quality Manual - Full [Unsigned]

QUALITY MANUAL

PHILLIPS PHARMACEUTICALS (TANZANIA) LIMITED

DOCUMENT NUMBER ISSUE NUMBER SUPERSEDES EFFECTIVE DATE

PPTL/QM/001 02 01 14.12.2018

NO PROCESS FOCUSES ON

Charting the Organization’s Direction and Growth, supporting the

development of an enabling environment, leading and guiding the
1 Top Management
staff, organizing structure and roles and spear-heading process

development in order to achieve company objectives.

Supporting the recruitment and development of staff and the

2 Human Resources maximizing of the partnership between the staff and the organization

thus achieving the organization’s goals.

Ensuring the organization adheres to various statutory requirements,

provision of required equipment and consumables and spear-
heading the management of contracted services and external service
Administration & Information
3 providers and ensuring IT infrastructure of the organization is well
Technology
established, maintained, and improved as per the demands of the

organization and market demands and providing IT solutions where

necessary.

Ensuring appropriate planning, availability and utilization of financial

4 Finance & Accounts resources to support the achievement of the organization’s desired

results.

Facilitating the establishment, implementation, maintenance and

continuous improvement of a QMS in order to consistently satisfy

5 Quality Assurance customers and meet statutory and regulatory requirements as well as

ensuring a robust quality assurance framework is established and

implemented.

Ensuring that commodities procured are received, stored, handled

6 Warehousing and processed safely and efficiently as per the Good Distribution

Practice and Regulatory requirements.

Liaising with the consumers and customers to ensure that their

7 Customer Support commodity needs are met and enquiries handled in line with

contracting entity requirements and regulatory guidelines.

Ensure products are packed, dispatched, transported and delivered as

8 Distribution per customer needs as well as contracting entity requirements and

regulatory guidelines

Ensuring compliance with statutory and regulatory requirements
9 Regulatory Affairs & Compliance
primarily related to product, premises and processes.

Facilitating the establishment of adverse event reporting framework

within the organization and being a focal point of contact for any
10 Pharmacovigilance
adverse related information for the principals and also the regulatory

bodies.

Ensuring that commodities are procured, handled and cleared from

11 Import & Export the port efficiently as per the Good Distribution Practice and

Regulatory requirements.

4.4.2 To the extent necessary PPTL has done the following:
• Maintained Documented Information to support the Operation of its Processes.

• Retained Documented Information to have confidence that the processes are being carried out as planned.

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