Page 15 - 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

7.1.4 ENVIRONMENT FOR THE OPERATION OF PROCESSES

PPTL has determined, provided and maintained the environment necessary for the operation of its processes and to

enable it achieve conformity of products and services.

• The temperature and humidity of the warehouses and the storage areas is monitored as stated in the SOP
Number PPTL/SOP/DH/013.

• The environment and equipment are appropriately maintained by ensuring a clean and pest free environment
as stated in the SOP Numbers PPTL/SOP/DH/006, PPTL/SOP/DH/012 and PPTL/SOP/AD/004.

• Ensuring that the equipment are serviced and calibrated and the storage areas are validated or qualified as
stated in the SOP Numbers PPTL/SOP/DH/010 and PPTL/SOP/DH/018.

• There is a designated area for the staff to refresh themselves. The management ensures a calm and non-
discriminatory environment that is suitable for the staff.

• The EHS Committee ensures that the working environment in the company’s offices and warehouse areas is
suitable at all times to achieve conformity to product requirements as stated in the SOP Number

PPTL/SOP/AD/004.

• The company ensures that physical and physiological factors that can affect the products output and

employee’s efficiency are also considered. This shall be handled by the EHS Committee as stated in the

PPTL/SOP/AD/004.

• PPTL provides where necessary Protective Clothing (PPE) such as overcoat, cold room jacket, safety boots

especially to warehouse employees as stated in stated in the SOP Number PPTL/SOP/AD/001.

7.1.5 MONITORING AND MEASURING RESOURCES

7.1.5.1 GENERAL

PPTL has determined and provided the resources needed to ensure valid and reliable results when monitoring or

measuring is used to verify the conformity of products and services to requirements.

PPTL has ensured that the resources provided are suitable for the specific type of monitoring and measurements

undertaken.

• For monitoring of temperature and humidity we have a Remote Monitoring System in place that monitors
continuously and alerts responsible staff of any excursion through an SMS and email alerts.

• All the equipment used for measurements is calibrated annually to ensure their continuing fitness for purpose.

7.1.5.2 MEASUREMENT TRACEABILITY

Measuring Traceability is a requirement and is considered by PPTL as an essential part of providing confidence in the

validity of measurement results. In this regard the measuring equipment used such as data loggers and thermo

hygrometers for monitoring temperature and humidity to ensure conformity to products requirements are:

• Calibrated annually against measurement standards traceable to the national measurements standards
provided by Tanzania Bureau of Standards (TBS).

• Has been identified and a schedule maintained showing calibration/inspection status.
• Safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and

subsequent measurement results.

7.1.6 ORGANIZATIONAL KNOWLEDGE

PPTL has determined the knowledge necessary for the operation of its processes and to achieve conformity of

products and services. The knowledge shall be maintained and made available to the extent necessary. Some of the

way the knowledge will be maintained will be through:

• QMS documentations including Quality Policy, Quality Manual, SOPs for all the processes, and Quality

Objectives and various records and other relevant documents/guidelines that we refer to.

• Hand over notes from the process leads detailing their work, the reports needed and key contacts for their

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