Page 21 - PPTL.QM.001 Iss 01 - ISO 9001 Quality Manual - Full [Unsigned]
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QUALITY MANUAL
PHILLIPS PHARMACEUTICALS (TANZANIA) LIMITED
DOCUMENT NUMBER ISSUE NUMBER SUPERSEDES EFFECTIVE DATE
PPTL/QM/001 02 01 14.12.2018
PPTL has determined and applied a criterion for the evaluation, selection, monitoring of performance and re-
evaluation of external providers based on their ability to provide processes or products and services in accordance
with requirements. PPTL will maintain documented information of these activities and any necessary actions arising
from the evaluations as stated in the SOP Numbers PPTL/SOP/QA/011 – Subcontractor Management and
PPTL/SOP/BD/007 – Prequalification of Suppliers that is done at the Group/Headquarters Level.
8.4.2 TYPE AND EXTENT OF CONTROL
PPTL shall ensure that externally provided processes, products and services do not adversely affect the organization’s
ability to consistently deliver conforming products and services to its customers.
PPTL shall:
• Ensure that externally provided processes remain within the control of its QMS.
• Define both the controls that it intends to apply to an external provider and those it intends to apply to the
resulting output.
• Take into consideration:
o The potential impact of the externally provided processes, products and services on the organization’s
ability to consistently meet customer and applicable statutory and regulatory requirements;
o The effectiveness of the controls applied by the external provider;
• Determine the verification, or other activities, necessary to ensure that the externally provided processes,
products and services meet requirements as stated in the SOP Numbers PPTL/SOP/QA/011 – Subcontractor
Management and PPTL/SOP/BD/007 – Prequalification of Suppliers.
8.4.3 INFORMATION FOR EXTERNAL PROVIDERS
PPTL shall ensure the adequacy of requirements prior to their communication to the external provider. PPTL shall
communicate to external providers its requirements for:
• The processes, products and services to be provided.
• The approval of:
o Products and services.
o Methods, processes and equipment.
o The release of products and services.
• Competence, including any required qualification of persons.
• The external provider’s interactions with the organization.
• Control and monitoring of the external provider’s performance to be applied by the organization.
• Verification or validation activities that the organization, or its customer, intends to perform at the external
provider’s premises as stated in the SOP Numbers PPTL/SOP/QA/011 – Subcontractor Management and
PPTL/SOP/BD/007 – Prequalification of Suppliers.
8.5 PRODUCTION AND SERVICE PROVISION
8.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION
PPTL has implemented production and service provision under controlled conditions. Controlled conditions shall
include, as applicable:
• The availability of documented information that defines the characteristics of the products to be produced,
the services to be provided, or the activities to be performed example expiry date of products and the results
to be achieved. The procedures are maintained as SOPs and Quality Objectives are set the targets that are to
be met.
• The availability and use of suitable monitoring and measuring resources. The availability of Tally. ERP software
for tracking of customer orders, installation and implementation of Temperature Remote Monitoring System
for monitoring storage temperature of pharmaceutical products and a Turn Around Time Stamp for
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