GENERAL INSTRUCTIONS STANDARD OPERATING PROCEDURE

Doc. No: SOP/QA/055

REGARDING SAFETY AND Doc. Version: 01 w. e. f: Oct-2009
HYGIENE

Searle Pakistan Limited Lahore

Written By Reviewed by Approved by

Q.A. Officer Q.A. Manager Head of Production

DISTRIBUTION LIST

DISTRIBUTION COPY # COPY HOLDER SIGNATURE

o 1 Head of Production
o 2 Q.A. Manager
o 3 Q.A. Officer
 GENERAL INSTRUCTIONS STANDARD OPERATING PROCEDURE
Doc. No: SOP/QA/055
REGARDING SAFETY AND Doc. Version: 01 w. e. f: Oct-2009
HYGIENE

AMENDMENT SHEET

REV. # DATE PAGE # SECTION # NATURE OF AMENDMENT

 GENERAL INSTRUCTIONS STANDARD OPERATING PROCEDURE
Doc. No: SOP/QA/055
REGARDING SAFETY AND Doc. Version: 01 w. e. f: Oct-2009
HYGIENE

LIST OF CONTENTS

1. Objective

2. Scope

3. Responsibility

4. Procedure
 GENERAL INSTRUCTIONS STANDARD OPERATING PROCEDURE
Doc. No: SOP/QA/055
REGARDING SAFETY AND Doc. Version: 01 w. e. f: Oct-2009
HYGIENE

Objective
1.0 :
1.1 To maintain a high standard of safety and hygiene in the factory area.
1.2 To keep product safe and prevent the product and operators from any possible exposure to contamination.

2.0 Scope :
2.1 This procedure applies to all departments of Searle manufacturing facility.

3.0 Responsibility :
3.1 It is the responsibility of the departmental Managers to ensure the adherence to this SOP.
3.2 It is the responsibility of the personnel involved in different processing and testing activities, to follow this
Work Instruction.

4.0 Procedure :
[Note: Precautions]

a. Detailed safety & hygiene program should be established and adopted to the different needs within the factory
area. These should include procedures, relating to health, hygienic practices, clothing and safety of the
personnel.

b. All personnel should be trained for these procedures and should be followed in a very strict way by every one
working in production and other controlled areas.

c. These procedures should be a part of orientation program of each employee, appointed in the manufacturing
facility.

Every person entering the production area should wear proper uniform/garments (with minimum number
4.1 of
pockets), caps and shoes, appropriate to the area of activity.

4.2 To avoid the direct contact between the operator's hands and the products, suitable gloves should be used by
operators.

4.3 Personnel should be trained for proper gowning, hand washing and hygienic drying (with hand dryer) and
these procedures should be clearly displayed at their locations.

Eating, drinking, chewing, smoking or taking personal medication into the production area, change room,
4.4 and
storage area is prohibited.

Pre-medical examination of all permanent working staff must be

4.5 done.

4.6 A person with apparent illness or open lesions that may adversely affect the quality of pharmaceutical product
shall be excluded from direct contact.

4.7 Cleaning programs and cleaning procedures should be followed and recorded.
 GENERAL INSTRUCTIONS STANDARD OPERATING PROCEDURE
Doc. No: SOP/QA/055
REGARDING SAFETY AND Doc. Version: 01 w. e. f: Oct-2009
HYGIENE

4.8 The cleaning or sanitizing agents used for the cleaning of Production, QA or office block floors should be replaced
frequently such as Proceine 40 or Vanaquat disinfacting solution may be replaced with each other after six months.

4.9 All areas should be frequently monitored Microbiologically, especially water taps and drains.
4.10 An appropriate action must be taken as soon as the results deviate significantly from the specified limits.

4.11 Separate mops should be used according to different processing areas.

4.12 Dry sweeping is forbidden in the production area.

4.13 Area should be kept free from insects and rodents. A proper rodent and pest control program should be
available in the plant.

4.14 Weighing of materials should be carried out in separate, controlled dispensing room.

Washing and cleaning of all the equipment should be controlled in order to avoid contamination. (Mops
4.15 should
be hung up so that they can be easily dried).

Room temperature and humidity should be maintained at level which will not cause excessive sweating of
4.16 oper-
ators, wearing protective garments.

4.17 The cleaning and sanitation procedures must be properly documented and validated as necessary.

Waste materials should not be allowed to accumulate. Special care is necessary over the disposal of waste
4.18 con-
taining dangerous or highly toxic materials.

4.19 Wear safety shoes, where ever is required according to work instructions.

4.20 Wear safety protective equipment while handling steam or working with hot surfaces

4.21 Do not bring the disinfectant solution bottle containing flammable materials, near the flame.

4.22 Equipment should be installed in such a way as to prevent any risk to product and operator.

Defective equipment should, if possible, be removed from the processing area, or at least be clearly labeled
4.23 as
defective.

4.24 Glassware should not be used in compounding area, alternatively plastic wares can be used for measuring or
other handling purpose.

4.25 Broken glassware should not be used in laboratory or other areas.

4.26 Emergency exits should be free i.e. without obstruction of pallets or other materials.
 GENERAL INSTRUCTIONS STANDARD OPERATING PROCEDURE
Doc. No: SOP/QA/055
REGARDING SAFETY AND Doc. Version: 01 w. e. f: Oct-2009
HYGIENE
4.27 Safety should promoted with the help of different safety slogans or through literature.

4.28 The fire drill should be a part of safety program.

Hazardous or explosive material should be stored in a proper area, having the facility exhaust fans,
4.29 explosion
proof lights etc.