STANDARD PROCEDURE FOR ASSURANCE OF DATA INTEGRITY
by Objective The objective of this procedure is to provide guideline for the entry and control of data in all forms of documentation in a consistent …
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SOP FOR CLEANING VALIDATION
Objective To Describe a Procedure for execution of Cleaning Validation Study. 2. Scope This SOP is applicable for execution of Cleaning Validation Study. …
SOP FOR PROCESS VALIDATION
OBJECTIVE To lay down a procedure for minimum requirement for validation or revalidation of manufacturing process applicable to marketed drug products in order to provide …
SOP FOR GOOD DOCUMENTATION PRACTICE
0 OBJECTIVE To lay down a procedure for good documentation practice in quality assurance, quality control, production and other departments. 2.0 SCOPE This SOP is …
Hold time study of pharmaceutical products during manufacturing
1.0 OBJECTIVE To lay down the procedure for conducting the hold time study of pharmaceutical products during manufacturing at every stage of In – process …
MONITORING THE TEMPERATURE AND RELATIVE HUMIDITY OF AREAS
1.0 OBJECTIVE To lay down a procedure for monitoring Temperature, Relative Humidity. 2.0 SCOPE The SOP is applicable to monitoring the temperature & …
APPROVAL OF ARTWORK
1.0 OBJECTIVE To lay down a procedure for the preparation and approval of art works 2.0 SCOPE This SOP is applicable for approval of …
SOP FOR CORRECTIVE AND PREVENTIVE ACTION
1.0 OBJECTIVE To lay down the procedure to be followed for the administration of corrective and preventive actions (CAPA) including tracking and reporting of …
RELEASE OF FINISHED GOODS
1.0 OBJECTIVE To provide guidelines for release of finished products for sale and distribution. 2.0 SCOPE 2.1 This SOP is applicable for release of …
HANDLING OF BATCH MANUFACTURING DOCUMENT ISSUANCE AND RECEIPT
1.0 OBJECTIVE To provide guideline for Issue, Receipt and Storage of Batch Manufacturing documents. 2.0 SCOPE This SOP is applicable for Issue, receipt …