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Planning Procedure

Doc. Id No.
QSP-520-01
DATE
10.04.14

REVISION
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Quality System
Procedure
QSP- 520-Planning Procedure
Revision No. : 1
Effective Date:

Page

Planning Procedure
1.0

3.2

3.3

3.4

Operation Manager
Main role in planning the involvement process to produce a product.
Evaluate and approval of the procedure planning of each process.

Planning
1.

3.1

The procedure defined the planning in junction to produce an API compliance product.

Responsibilities
1.

3.0

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Purpose
1.

2.0

Doc. Id No.
QSP-520-01
DATE
10.04.14

The planning process shall consider the below key points.

Human Resource
1.

PTBMI shall ensure the human resource which directly or un-directly affected the product
quality and safety is well under control and measureable.

2.

The qualification and competence of the human resource shall be the key indicator in the
evaluation program.

3.

The training shall be organize planned with the frequent and efficient shall be main
consideration.

4.

Detail description of the process can be located in QSP-4322-01.

Environment Resource
1.

The environment resource shall include the facilities in the PTBMI premise such as ,
equipment, tools and working environment.

2.

The planning shall include the usage, control and maintain of the environment resource.

Detail of the environment resource managing and planning is listed in QSP-578-01.

Product and Customer Specific Requirement


1.

For every manufacture or production process planning, the PTBMI shall consider the
product specification and customer specific requirement.

2.

All the info related to the manufacture process need to be evaluate and confirmed before
the manufacture process can be start.

3.

PTBMI shall ensure the product specification and customer specific requirement did not
collide with the API standard and regulatory.

4.

Detail process description is listed in QSP-510-01.

Design and Development

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Planning Procedure

3.5

3.6

Doc. Id No.
QSP-520-01
DATE
10.04.14

REVISION
1
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1.

When planning on the design and development, the PTBMI shall consider the standard
and regulatory which shall be the basic of the product requirement.

2.

The design and development planning shall consider the definition of the process
involved, competency of the involved personal, verification and validation of each process
and acceptance criteria of the design.

The detail procedure is listed in QSP-540-01.

Inspection and Testing


1.

For inspection and testing planning shall include the inspection criteria, acceptance
criteria, reference standard, personal competency and related documents.

2.

Inspection and testing shall include receiving inspection, in-process inspection and final
inspection.

3.

Detail of the inspection and testing is located in QSP-577-01.

Control of record
1.

The control of record process shall be planned based on to identify the controls and
responsibilities needed for the identification, collection, storage, protection, retrieval,
retention time, and disposition of records.

2.

Records shall be the only evidence that the product realization processes meet
requirements.

3.

Records shall be retained for a minimum of ten years.

4.

Detail of the process is listed in QSP-443-01, QSP-450-01.

3.7

Contingency Planning

1.

The contingency shall be planned based on the risk associated with impact on delivery and quality
of product.

2.

Contingency planning shall be based on assessed risks and output shall be documented and
communicated to the relevant personnel and updated as required.

3.

Detail of the process is located in QSP-530-01.

3.8

Management of Change
1.

The management of change (MOC) shall be planned to ensure that the integrity of the
quality management system is maintained when changes to the quality management
system are planned and implemented.

2.

The MOC planning shall include the identified potential risks associated with the change
and any required approvals prior to the introduction of such changes.

3.

The MOC planning also include the records or document required for the MOC activities.
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Planning Procedure
4.

Doc. Id No.
QSP-520-01
DATE
10.04.14

REVISION
1
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Detail procedure is located in QSP-511-01.

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