Page 23 - 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

storage at the warehouse and during internal processing of orders as well as whilst in transit to the intended

destination by following WHO and EU GDP Guidelines. This includes identification, storage, handling, packaging and

protection as stated in the SOP Numbers PPTL/SOP/DH/002 – Receipt of Goods, PPTL/SOP/DH/004 – Receipt of Cold

Chain Goods, PPTL/SOP/DH/006 - Housekeeping, PPTL/SOP/DH/009 – Storage of Goods, PPTL/SOP/DH/010 –
Distribution Hub Mapping, PPTL/SOP/DH/011 – Handling Spillages, PPTL/SOP/DH/012 – Pest Control,

PPTL/SOP/DH/013 – Temperature and Humidity Monitoring, PPTL/SOP/DH/015 – Fate of Unfit Goods,
PPTL/SOP/DH/020 – Delivery of Goods and PPTL/SOP/DH/021 – Evolving GDP Guidelines.

8.5.5 POST DELIVERY ACTIVITIES

PPTL shall meet requirements for post-delivery activities associated with the products and services. PPTL accepts

returns from customers as stated in the SOP Number PPTL/SOP/DH/014 – Handling Returned Goods. In determining

the extent of post - delivery activities that are required, PPTL shall consider:

• Statutory and regulatory requirements.

• The potential undesired consequences associated with its products and services.
• The nature, use and intended lifetime of its products and services.

• Customer requirements, that are determined using different sources as stated in the Clause 4.2 and are
reviewed annually during the Management Review Meeting as stated in the SOP Number PPTL/SOP/QA/009.

• Customer feedback using the SOP Number PPTL/SOP/CS/003

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.

8.5.6 CONTROL OF CHANGES

PPTL shall review and control changes for production or service provision, to the extent necessary to ensure

continuing conformity with requirements. A procedure on change control, PPTL/SOP/QA/003 has been established to

ensure that all major changes related to the maintenance of the PPTL QMS and Good Distribution Practice are

reviewed, approved and communicated appropriately before implementation. PPTL shall maintain documented

information describing the results of the review of the changes, the person authorizing the change and the necessary

actions arising from the review.

8.6 RELEASE OF PRODUCTS AND SERVICES
PPTL shall implement planned arrangements, at appropriate stages, to verify that the product and service

requirements have been met. The release of products and services to the customer shall not proceed until the planned

arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, as

applicable, by the customer. The organization shall retain documented information on the release of products and

services. The documented information shall include evidence of conformity with the acceptance criteria example: copy

of customer in comparison to the delivery note to customer and traceability to the person(s) authorizing the release

example: signatures stores and dispatch personnel releasing the order as stated in the SOP Number

PPTL/SOP/DH/007, PPTL/SOP/DH/008 and PPTL/SOP/DH/020. Release of any pharmaceuticals products into the

market shall only occur if they are registered as per the SOP Number PPTL/SOP/RA,001, and cleared by QA as per the

SOP Number PPTL/SOP/DH/002 and PPTL/SOP/DH/004, and the orders going through the supply chain undergoes

release at each point of the chain as stated in the SOP Numbers PPTL/SOP/DH/008, PPTL/SOP/CS/002 and

PPTL/SOP/DH/020. Any release of returns is controlled as stated in the SOP Number PPTL/SOP/DH/014.

8.7 CONTROL OF NONCONFORMING OUTPUTS

8.7.1 The organization shall ensure that outputs that do not conform to their requirements are identified and

controlled to prevent their unintended use or delivery. The organization shall take appropriate action based on the

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