Page 22 - 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

monitoring the service delivery timelines.

• The implementation of monitoring and measurement activities at appropriate stages to verify that criteria for

control of processes or outputs, and acceptance criteria for products and services, have been met. The

availability of Tally. ERP software for tracking of customer orders, signature approvals through each stage of
the supply chain, installation and implementation of Temperature Remote Monitoring System for monitoring

storage temperature of pharmaceutical products and a Turn Around Time Stamp for monitoring the service
delivery timelines.

• The use of suitable infrastructure and environment for the operation of processes.

• The appointment of competent persons, including any required qualification. This is achieved through the
Human Resource SOP Number PPTL/SOP/HR/001.

• The validation, and periodic revalidation, of the ability to achieve planned results of the processes for
production and service provision, where the resulting output cannot be verified by subsequent monitoring or

measurement., calibration of equipment shall be as stated in the SOP Number SOP/PPTL/DH/018.

• The implementation of actions to prevent human error example through availability of SOPs, recruiting
competent staff as stated in the SOP Number PPTL/SOP/HR/001 and also engaging Risk Based Process

Approach and Planning as per the SOP Number PPTL/SOP/QA/010.

• The implementation of release, delivery and post - delivery activities. This is achieved through SOP Number

PPTL/SOP/CS/003 for Handling Complaints, 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.

8.5.2 IDENTIFICATION AND TRACEABILITY

The organization shall use suitable means to identify outputs when it is necessary to ensure the conformity of

products and services. The organization shall identify the status of outputs with respect to monitoring and

measurement requirements throughout production and service provision.

The organization shall control the unique identification of the outputs since traceability is a requirement for all
pharmaceuticals and retains the documented information necessary to enable traceability in an electronic ERP system

and also invoice copies, all of these by the use of batch numbers. This is to ensure identification through the

supply chain as stated in the SOP Number PPTL/SOP/DH/008.

8.5.3 PROPERTY BELONGING TO CUSTOMERS OR EXTERNAL PROVIDERS

PPTL shall exercise care with property belonging to customers or external providers while it is under the organization’s

control or being used by the organization. The organization shall identify, verify, protect and safeguard customers’ or

external providers’ property provided for use or incorporation into the products and services. PPTL exercises care over

customer property when receiving, handling, storing and distributing the various pharmaceutical and healthcare

commodities. In the event of loss or damage this is reported to the customer retain documented information on what

has occurred.

8.5.4 PRESERVATION

The organization shall preserve the outputs during production and service provision, to the extent necessary to ensure

conformity to requirements. Preservation will include identification, handling, contamination control, packaging,

storage, transmission or transportation, and protection.

Conformity of pharmaceutical drugs and healthcare commodities handled at PPTL is preserved during receiving,

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