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 heads shall ensure that all responsible operations

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

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.

4.4

The Department head shall ensure that the new or renewal

procedures shall be absolutely independence from the existing SOP.
GMP ASEAN GUIDELINE

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.
4.9.4

Equipment and Materials :

In general, brand names may not be included in descriptions;

relevant equipment parameters and/or specifications
that
are
GMP ASEAN GUIDELINE

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