STANDARD OPERATING PROCEDURE Preparation of Yearly Schedules

	STANDARD OPERATING PROCEDURE
	Department: Quality Control	SOP No.: QC/MB/
Preparation of Yearly Schedules		Effective Date:
		Review Date:
		Page No.:

1.0            OBJECTIVE:

1.1                   To lay down a procedure for preparation of yearly schedules.

2.0            SCOPE:

This procedure is applicable to yearly schedules of purified water, process water, raw water, Environmental monitoring by settle plate & air sampler method in production areas, compressed air testing and fumigation activity in microbiology department at Pharma Private Limited.

3.0            RESPONSIBILITY:

3.1                   Microbiologist/QC Designee: Responsible for preparation of yearly schedules

3.2                   QC Head: Responsible for implementing the Procedure.

3.3                   QA Head: Overall compliance.     

4.0            PROCEDURE:

4.1                   Prepare yearly schedules for Water samples, environmental monitoring, compressed air      testing and Fumigation as per the frequency mentioned in respective SOPs.

4.2                   Prepare purified water yearly schedule by using template mentioned in annexure –I and perform analysis as per schedule and enter the performed date along with sign.

4.3                   Prepare process water yearly schedule by using template mentioned in annexure –II and perform analysis as per schedule and enter the performed date along with sign.

4.4                   Prepare raw water yearly schedule by using template mentioned in annexure –III and perform analysis as per schedule and enter the performed date along with sign.

4.5                   Prepare environmental monitoring of production areas (settle plate method) yearly schedule by using template mentioned in annexure – IV and perform monitoring as per schedule and enter the performed date along with sign.

4.6                   Prepare environmental monitoring of production areas (air sampler method) yearly schedule by using template mentioned in annexure –V and perform monitoring as per schedule and enter the performed date along with sign.

4.7                   Prepare compressed air yearly schedule by using template mentioned in annexure –VI and perform analysis as per schedule and enter the performed date along with sign.

4.8                   Prepare fumigation activity yearly schedule by using template mentioned in annexure –VII and perform activity as per schedule and enter the performed date along with sign.

5.0            ABBREVIATIONS:

QC: Quality Control	QA: Quality Assurance
SOP: Standard Operating Procedure