SOP for Entry in Quality Assurance Department : Pharmaceutical Guidelines

SOP for Entry in Quality Assurance Department

Standard operating procedure for entry and exit in quality assurance department for vendors, visitors and housekeeping personnel.

1.0 OBJECTIVE

To define the lay down the procedure for all persons entering in the quality assurance department.

2.0 SCOPE

This procedure applies to the quality assurance department of the manufacturing facility.

3.0 RESPONIBILITY

Executive/ Manager Quality Assurance

4.0 ACCOUNTABILITY

Manager - Quality Assurance

5.0 PROCEDURE

5.1 Staff and workmen coming from other production block shall wear dedicated slippers provided in the change room near the staircase before entering into the laboratory.
5.1.1 Collect the clean linen/ factory dress from linen room once in three days or as and when required.
5.1.2 Put on factory dress (apron) in the changing room.
5.1.3 Shoe covers, slippers and caps are not required in the quality assurance department except in microbiological section.
5.1.4 Use dedicated slippers provided in the change room for going into the production area.

5.2 Exit

5.2.1 Enter into the changing room before leaving the respective department.
5.2.2 Remove factory dress and put in the locker provided for reuse.
5.2.3 Discard used an apron for washing in the change room.

5.3 For Vendors

5.3.1 Take vendors to the conference room for discussion (dress not required).
5.4 For Service Engineers
5.4.1 Provide white aprons (for visitors) to service engineers by the security department with visitor cap.
5.4.2 Deposit gate pass and white apron to security personnel after completion of the job in the respective department.

5.5 For Visitors

5.5.1 Provide important visitors with paper apron near the change room.
5.5.2 Discard used aprons in the bin provided near the change room after the visit is over.

5.6 For Housekeeping Staff

5.6.1 Enter in respective departments with proper dress provided.
5.6.2 Housekeeping personnel are to collect their dresses from respective linen room and dispose off for washing daily at the end of the day.

6.0 ABBREVIATIONS

6.1 SOP - Standard Operating Procedure

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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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