Total Pharmaceutical Solution

ALL POSTS

Handling of external laboratory analysis

1.0 PURPOSE: To lay down a procedure for handling of external laboratory analysis or contract laboratory tests results which are not performed in-house. 2.0 SCOPE: This procedure for handling of external laboratory analysis or contract

Read More »

Operation and maintenance of fire hydrant system

1.0 PURPOSE: To lay down the procedure for operation and maintenance of fire hydrant system. 2.0 SCOPE: This SOP is applicable to operation and maintenance of fire hydrant system located at (Company name). 3.0 DEFINITIONS:

Read More »

Procedure for control of analytical documents

1.0 PURPOSE: To lay down a procedure for control of analytical documents related to quality control department in quality assurance department. 2.0 SCOPE: This procedure for control of analytical documents applies to Report received from

Read More »

Monitoring of Microbiology Laboratory

1.0 PURPOSE: To provide the methods for routine monitoring of microbiology laboratory. 2.0 SCOPE: This procedure for monitoring of microbiology laboratory is applicable to Microbiology laboratory of (Company name). 3.0 DEFINITIONS: Nil. 4.0 RESPONSIBILITY: 4.1

Read More »

Procedure for Mock Drill

1.0 PURPOSE: To lay down procedure for mock drill. 2.0 SCOPE: This procedure for mock drill is applicable at (Company name). 3.0 DEFINITION: Nil. 4.0 RESPONSIBILITY: 4.1 Safety officer is responsible for execution as per

Read More »

SOP for stability studies of finished products

1.0 PURPOSE: To provide a procedure for stability studies of finished products which includes Receipt of samples, Incubation of sample and withdrawal of sample. 2.0 SCOPE: This procedure for stability studies of finished products is

Read More »

SOP for management of water quality

1.0 PURPOSE: To lay down a procedure for management of water quality. 2.0 SCOPE: This procedure for management of water quality is applicable for sampling, testing, approval and rejection of different types of water used

Read More »

SOP for acceptable quality level (AQL)

1.0 PURPOSE: To lay down procedure for conducting Acceptable Quality Level (AQL) for products at various stages; including Compression, Coating and Capsule filling. 2.0 SCOPE: This procedure conducting Acceptable Quality Level (AQL) is applicable to

Read More »

Procedure for cleaning of new equipment

1.0 PURPOSE: To lay down the procedure for cleaning of new equipment. 2.0 SCOPE: This procedure for cleaning of new equipment is applicable in Production Injectable, Warehouse and Production OSD area at (Company name). 3.0

Read More »

SOP for recording of burning hours of UV lamps

1.0 PURPOSE: To lay down the procedure for the recording of burning hours of UV lamps. 2.0 SCOPE: This procedure applicable for recording of burning hours of UV lamps at (Company name).  3.0 DEFINITIONS: Nil.

Read More »

Procedure for monitoring the lux level

1.0 PURPOSE: To lay down the Procedure for Monitoring the Lux level. 2.0 SCOPE: This procedure for monitoring the Lux level is applicable at (Company name). 3.0 DEFINITIONS: Nil. 4.0 RESPONSIBILITY: 4.1 Engineering personnel shall

Read More »

SOP for operation and cleaning of vaccum pump

1.0 PURPOSE: To provide the procedure for operation and cleaning of vacuum pump used in Quality control laboratory. 2.0 SCOPE: This procedure is applicable for operation and cleaning of vacuum pump used in (Company name).

Read More »

SOP for operation and cleaning of brine chiller

1.0 PURPOSE: To lay down the procedure for operation and cleaning of brine chiller. 2.0 SCOPE: This procedure for operation and cleaning of brine chiller is applicable for brine chiller located at (Company name). 3.0

Read More »

SOP for recovery test for clean room

1.0 PURPOSE: To lay down the Procedure for Recovery test for clean room. 2.0 SCOPE: This procedure applies for Recovery test for clean room at (Company name). 3.0 DEFINITIONS: Nil. 4.0 RESPONSIBILITY: 4.1 Engineering personnel

Read More »

SOP for cleaning validation in pharma

1.0 PURPOSE: To define comprehensive approach to the validation of cleaning procedure for equipment area used in manufacturing process. 2.0 SCOPE: This SOP for cleaning validation in pharma is applicable to cleaning validation at (Company

Read More »

SOP for Change control programme in pharma

1.0 PURPOSE: The purpose of the procedure for change control programme in pharma is to have documented procedure for initiation, evaluation, approval and implementation of change control. 2.0 SCOPE: 2.1 This procedure for change control

Read More »

Sop for handling of temporary change control

1.0 PURPOSE: To define the procedure for handling of temporary change control (Planned deviation) during operations. 2.0 SCOPE: This procedure for handling of temporary change control is applicable to all departments in (Company name). The

Read More »
Scroll to Top