Saturday, August 18, 2018

Technology Transfer Sample Protocol in Pharmaceuticals

In the pharmaceutical industry, “technology transfer” refers to the processes that are needed for successful progress from drug discovery to product development to clinical trials to...

SOP on Repackaging / Re-labeling of Finished Goods

1.0 Objective To lay down a procedure for Repackaging / Re-labeling of Finished Goods. 2.0 Scope The scope of this standard operating procedure is applicable for Finished...

Review, Storage, Retrieve and Disposal of Executed Batch Documents

Objective To lay down the procedure for Review, Storage, Retrieval and disposal of Executed Batch documents. Scope This SOP covers the procedures for Review, Storage, Retrieval and...

SOP on Status Labeling System and Its Control

1.0 Objective: To lay down a procedure for the status labeling system and its control. 2.0 Scope: This Standard Operating Procedure is applicable for identification...

SOP On Facility Designing and Qualification

1.0 Objective To define the Standard Operating Procedure for Facility Designing and Qualification. 2.0 Scope 2.1 This SOP is applicable for pharmaceutical Facilities. 2.1.1 When designing new facility. 2.1.2...

Assigning Manufacturing and Expiry Date

Objective: To lay down a procedure for assigning manufacturing and expiry date to the finished products being manufactured. Scope: This SOP is applicable for assigning manufacturing and...

SOP for Management of Equipment

Objective To lay down a procedure for Management of Equipment. Scope This SOP is applicable for Management of Equipment. Responsibility Respective heads of user departments shall be responsible of...

Hold Time Study …..current approach

Hold Time Study Approach...... It is an expectation of regulatory organizations that companies establish and monitor clean and dirty equipment hold times for manufacturing equipment...

Protocol for  Validation of Sterilization Process using Steam Sterilizer (Bung Processor)

Protocol For Validation Of Sterilization Process Using Steam Sterilizer (Bung Processor) Equipment ID Aseptic Processing Area Location: Pharmaceutical Company Document No. Supersedes Effective Date No. of Pages   PROTOCOL CONTENTS Sr. No.            ...

Untouched area of Data Integrity in Pharmaceutical Industry

Now a days the topic "Data integrity and non compliance" is the hot topics. Lots of references available online that deals with the Data...