Page 24 - 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

nature of the nonconformity and its effect on the conformity of products and services. This shall also apply to

nonconforming products and services detected after delivery of products, during or after the provision of services.

The organization shall deal with nonconforming outputs in one or more of the following ways:

• Correction.

• Segregation, containment, return or suspension of provision of products and services.

• Informing the customer.

• Obtaining authorization for acceptance under concession.

• Conformity to the requirements shall be verified when nonconforming outputs are corrected.

8.7.2 The organization shall retain documented information that:

• Describes the nonconformity.

• Describes the actions taken.

• Describes the concessions obtained.

• Identifies the authority deciding the action in respect of the nonconformity.

A documented procedure, Procedure for Control for Nonconforming Outputs – Handling Deviations

PPTL/SOP/QA/006 is in place to ensure that product and service which does not conform to requirements is

identified and controlled to prevent its unintended use or delivery. Non-conforming product and service is

dealt with in one of the following ways:

• By taking action to eliminate the detected nonconformity.

• By taking action to preclude its original use or application.

Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained,

are maintained. When non-conforming product is detected after collection, delivery, or use has started, Phillips

Pharmaceuticals (Tanzania) Limited takes action appropriate to the effects, or potential affects, of the

nonconformity. Procedures for monitoring the effects of the products in the market is covered by a separate

Quality manual altogether – PPTL/QM/002 – Pharmacovigilance Quality Manual.

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