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1.

2.0

3.0

4.0

Purpose
1.1

This procedure is to describe a standardized form and


format for Standard Operating Procedures (SOPs ).

1.2

This procedure is to define guidelines for drafting and


writing of Standard Operating Procedures.

Scope
2.1

All procedures and operations that may directly or


indirectly affect product manufacture and product quality
shall be clearly written as Standard Operating Procedures.

2.2

All personnel who are responsible for writing SOPs shall be


trained in this procedure.

Responsibility
3.1

Designated individuals in each Department or functional


designation shall have responsibility of writing SOPs.

3.2

Department
operations
documented
engaged are
SOPs.

3.3

Department heads and for those responsible for SOP


writing shall ensure that their responsible SOPs are up to
date and reflect the current practices.

heads shall ensure that all responsible


pertaining to GMP manufacturing are
in appropriate SOPs and all personnel
trained in the application and importance of

Procedure
4.1

All procedures which directly or indirectly affect the quality


of the product must be documented as SOPs. These are
written procedures that are concise and precise step by
step written procedures that describe the given operation
or function simply and effectively so as to ensure
reproducibility regardless of operator.

4.2

SOPs must reflect the actual and current practices for that
procedure.

4.3

SOP shall be prepared or revised whenever a new


operating procedure is adopted or when an existing
procedure needs to be updated, as determined by the
responsible individuals.

GMP ASEAN GUIDELINE

4.4

The Department head shall ensure that


the new or
renewal procedures shall be absolutely independence from
the existing SOP.

4.5

SOP shall be written in point form.

4.6

SOPs shall contain the following sections, in the following


order, where applicable :
1. Purpose
2. Scope
3. Responsibility
4. Reagents and chemicals
5. Equipment and materials
6. Safety considerations
7. Procedure / other appropriate heading / additional
sections
as
necessary
necessary

4.7

Purpose, scope and responsibility are mandatory sections


in any SOP and must be addressed. Additional sections
may be addressed if necessary.

4.8

Sections on procedure, reagents & chemicals, equipment &


materials and safety considerations, shall be addressed
where applicable and may be omitted otherwise as
exemplified by this SOP.

4.9

Definitions
4.9.1 Scope :
It shall describe who and what the procedure does and
does not apply to and/or when it is applied. The scope of a
SOP declares the extent of the procedure described.
4.9.2 Responsibility :
It shall declare the individuals and/or department who take
responsibility for executing or supervising this activity.
4.9.3 Reagents and Chemicals :
In general, reagents and chemicals shall be consistent
throughout all SOPs, use common universal terms and
include pertinent information such as concentration and
sterility.
GMP ASEAN GUIDELINE

4.9.4 Equipment and Materials :


In general, brand names may not be included in
descriptions; relevant equipment parameters and/or
specifications that are required by the procedure shall be
listed instead. Only when the piece of equipment cannot
generally be substituted by an equivalent, are brand
names included.
4.9.5 Safety Considerations :
It may include biological contamination issues ( e.g. masks,
gloves, biological safety cabinets ), physical issues ( e.g.
goggles, hard hats), and chemical hazards (e.g. spill
cleanup ) whenever appropriate.
4.9.6 Procedure and additional procedural :
The procedure should use step by step point form with
simple and clear wording to explain how to perform the
task in a manner that supports process control. Diagrams
may be included where necessary.
4.10 It shall be submitted for review and approval to the
Department Head or Plant Manager where applicable after
a drafted SOP is completed.

GMP ASEAN GUIDELINE

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