Page 18 - 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

LEVEL 3: OTHER DOCUMENTS FOR EFFECTIVE CONTROL OF PROCESSES

All other documents supporting QMS such as standard operating procedures and work instructions, if

necessary, are controlled as per procedure for control of maintained documented information, PPTL/

SOP/QA/003.

LEVEL 4: RETAINED DOCUMENTED INFORMATION
Relevant quality documented information shall be retained in the PPTL reporting systems as evidence of

accomplishment of set objectives. This will be controlled as per procedure for control of retained documented

information, PPTL/SOP/QA/004.

7.5.2 CREATING AND UPDATING

When creating and updating documented information PPTL has ensured:

• Identification and description (title, date and reference number) where applicable.

• Format and Media.
• Review and approval for suitability and adequacy.

7.5.3 CONTROL OF DOCUMENTED INFORMATION

7.5.3.1 Documented information required by PPTL QMS and by ISO 9001 Standard shall be controlled to ensure it is

available and suitable for use, where and when it is needed and is adequately protected from loss of confidentiality,

improper use and loss of integrity as stated in the SOP Number PPTL/SOP/QA/003.

7.5.3.2 For the control of documented information, PPTL has addressed the following:

• Distribution, access, retrieval and use.

• Storage and preservation, including preservation of legibility.

• Control of changes.

• Retention and disposition.

Documented information of external origin determined by the organization to be necessary for the planning and

operation of the QMS shall be identified as appropriate and controlled. Documented information retained as evidence
of conformity shall be protected from unintended alterations. The company controls QMS documentation to

ensure that correct documents are used as stated in detail in SOP Numbers PPTL/SOP/QA/003 and

PPTL/SOP/QA/004. We promptly remove all obsolete/invalid documents from all points of issue, therefore

preventing unintended use. Documents to be retained, and records of quality performance, are controlled,

maintained and protected. The company employs necessary controls to ensure that the latest copies of all

documentation relevant to the accomplishment of work are available at the time and place of work, thus

enabling the effective functioning of organization’s QMS.

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