SOP for Discipline in Manufacturing Area : Pharmaceutical Guidelines

SOP for Discipline in Manufacturing Area

Standard operating procedure to maintain discipline in manufacturing area including personal hygiene, uniform and personnel movement in classified area.

1.0 PURPOSE

The purpose of this SOP is to provide a procedure for discipline for persons working/ entering the Production area.

2.0 SCOPE

This SOP is applicable to all the persons entering and working in the Production Department.

3.0 RESPONSIBILITY

To all concerned personnel

4.0 ACCOUNTABILITY

HOD Production

5.0 PROCEDURE

5.1 General

5.1.1 Employees shall follow the entry and exit procedure before entering the Production areas.
5.1.2 Every employee working in Production should follow all the given instructions.
5.1.3 Prior intimation has to be given in case of absenteeism from duty.
5.1.4 In case of communicable or contagious disease, the employee will produce fitness certificate prior to entering the production area.
5.1.5 They should not wear any jewelry, watch, bindi.
5.1.6 They should not do whistling and singing in the production area.
5.1.7 They should not carry any eatables, smoking & chewing materials inside the Production.
5.1.8 They should not be carrying any medicines in their pockets, if they have then it will be kept in in-change room or security office.
5.1.9 Female employees should wipe out their makeup and wash their face (for any cosmetics) before entering into the production area.
5.1.10 After using toilet wash hands with soap solution and dry them.
5.1.11 Employees should not sneeze or cough near to the product.
5.1.12 Every employee shall wash and dry their hands before leaving the production area.

5.2 Personal Hygiene

5.2.1 Every person working in Production should have a bath every day.
5.2.2 They should have a clean shave.
5.2.3 Hair should be cut short.
5.2.4 The nails should be trimmed short and clean, no polish shall be on the nails
5.2.5 Employees suffering from major illness or having open injuries should not enter the core production area.

5.3 Uniform

5.3.1 Every employee will wear designated factory uniform before entering into the production area.
5.3.2 Employee will wear secondary gowning before entering the core area.
5.3.3 Employees should not touch any Drug product, Raw material with bare hands.

5.4 Movement in the Production Department

5.4.1 Movement in Production department should be minimum.
5.4.2 Employee should not come out of core area other than for breaks or in case of emergency.
5.4.3 Frequency of opening and closing of the doors should be minimum and has to be done slowly.

5.5 Air Locks

5.5.1 While using airlock always ensure that anyone door is opened at one time, and while opening one door ensure that the other door is in the closed position.

6.0 ABBREVIATIONS

6.1 SOP: Standard Operating Procedure
6.2 HOD: Head of Department

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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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