Page 20 - 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

8.2.3 REVIEW OF THE REQUIREMENTS FOR PRODUCTS AND SERVICES

8.2.3.1 PPTL shall ensure that it has the ability to meet the requirements for products and services offered to

customers. The organization shall conduct a review by cross-confirming the requirements with the customer as stated

in the SOP Number PPTL/SOP/CS/002 before committing to supply products and services to a customer to include
the following:

• Requirements specified by customer.

• Requirements not stated by customer but necessary for the specified or intended use, when known.

• Requirements specified by the organization.

• Statutory and regulatory requirements applicable to the products and services.

• Contract or order requirements differing from those previously expressed.

PPTL will ensure that contract or order requirements differing from those previously defined are resolved. The

customer requirements shall be confirmed by the organization before acceptance, when the customer does not

provide a documented statement of their requirements, example: an email or a purchase order as per the SOP Number

PPTL/SOP/CS/002.

8.2.3.2 The organization shall retain documented information, as applicable on the following:

• Results of the review (See Appendix X).

• Any new requirements for the products and services (See Appendix X).

8.2.4 CHANGES TO THE REQUIREMENTS FOR PRODUCTS AND SERVICES

PPTL shall ensure that relevant documented information is amended, and that relevant persons are aware of the

changed requirements, when the requirements for products and services are changed as stated in the SOP Number

PPTL/SOP/CS/002 – Receipt of Orders.

8.3 DESIGN AND DEVELOPMENT OF PRODUCTS AND SERVICES

This particular clause is not applicable to the PPTL QMS since the organization is not involved in design and
development of products and services. The fact that this particular clause is not applicable does not affect the

PPTL’s ability, or responsibility to ensure conformity of its products and services and enhancement of customer
satisfaction. We confirm the quality of the products we receive through our internal quality control activities as

stated in the SOP Number – PPTL/SOP/DH/002 – Receipt of Goods and through GMP Inspections that are

conducted by the TFDA.

8.4 CONTROL OF EXTERNALLY PROVIDED PROCESSES, PRODUCTS AND SERVICES

8.4.1 GENERAL

PPTL has put measures in place to ensure that externally provided processes, products and services conform to

requirements. The organization has determined the controls to be applied to externally provided processes, products

and services when:

• Products and services from external providers are intended for incorporation into the organization own

products and services.

• Products and services are provided directly to the customers by external providers on behalf of PPTL.

• A process or part of a process is provided by an external provider as a result of a decision made by PPTL.

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