Page 14 - 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

7.0 SUPPORT

7.1 RESOURCES

7.1.1 GENERAL

PPTL has determined and provided the resources needed for the establishment, implementation, maintenance and

continual improvement of the QMS. The organization has considered the capabilities of, constraints on, existing

internal resources and what needs to be obtained from external providers.

The PPTL management provides the resources needed to develop, implement and continually improve the

processes of the Quality Management System and to address and enhance customer satisfaction in a timely

manner to ensure requirements are met.

7.1.2 PEOPLE

The organization has determined and provided the persons necessary for the effective implementation of its QMS and

for the operation and control of its processes (see Appendix VIII – PPTL/QMS/QA/024). PPTL ensures that personnel

performing work affecting the company’s Quality Management System are competent on the basis of

applicable education, training, skills and experience, see SOP Number PPTL/SOP/HR/001 and

PPTL/SOP/HR/006.

PPTL is staffed by a blend of experienced personnel including pharmacists who are skilled in their areas of

operation. The hierarchical structure of PPTL Company is as shown in Appendix VIII – PPTL/QMS/QA/024. PPTL
ensures that the responsibilities, authority and the interrelation of all personnel who manage, perform and

verify work affecting quality are defined and communicated in order to facilitate effective quality management.

All key personnel have been given authorities and responsibilities to enable them to assist in the achievement

of the quality objectives. This assignment of authority and responsibility helps to establish involvement and

commitment of people throughout Phillips Pharmaceuticals (Tanzania) Limited.

The responsibility of personnel is given. An individual may be appointed with a dual role (within the Phillips

Pharma Group Tanzania), in such cases he/she will be responsible for fulfilling the tasks assigned to both roles.

The company issues job descriptions to personnel and maintains a copy in personnel records as stated in SOP

Number PPTL/SOP/HR/003 – Staff Record Maintenance.

7.1.3 INFRASTRUCTURE

PPTL has determined, provided and maintained an infrastructure necessary for the operation of its processes and to

enable it achieve conformity of products and services. These resources include:

• Warehouses for storage of products at ambient temperature, cold rooms, refrigerators, freezer room, freezers

for products that require cold storage.

• Equipment example: hand pallets, trolleys and pallet shifters.

• Transportation resources in terms of vans, trucks and motor bikes.

• An enterprise resource planning system, internet and phone services for information management and

communication.

The Distribution Hub Manager in collaboration by Quality Assurance Manager, with support from the Management

Team determines, provides and arranges maintenance for the infrastructure needed to achieve the conformity of the

service requirements, including buildings, workspace and associated facilities, process equipment such as cold room,

computer hardware and software, communication media, transport and supporting services.

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