Wednesday, December 12, 2018

SOP on Guideline for Preparation of Site Master File

Objective To write a guideline for preparing Site master File (SMF). Scope This Sop is applicable for preparation of Site master file. Responsibility QA Personnel Head QA, Procedure Site Master File (SMF)...

SOP on Change Control Management

Objective To write a procedure for change control management Scope All the changes in documents, facility, equipment, system etc. Responsibility Head QA, Head production Plant head Procedure Change control: Change control is a...

SOP on Market Complaints

Objective To write a procedure for handling and Management of Market complaints Scope All the complaints oral and written Market complaints received. Responsibility Head QA, Head production Plant head Procedure A complaint defines...

SOP on Preparation & Handling of Un-blinding Envelopes

1.0 Objective To lay down a procedure for preparation and handling of un-blinding envelopes meant for un-blinding of patient kits of Clinical Trial Study. 2.0 Scope This...

SOP on Disposal of Expired or Obsolete Raw Materials

1.0 Objective To lay down Procedure for Disposal of Expired or Obsolete Raw Materials. 2.0 Scope This Standard Operating Procedure is applicable for disposal of expired or...

SOP on Acceptable Quality Level (AQL) During Product Inspection for physical defects

” Product Inspection for Physical defects ” shall be filed in the Batch Production Record of the respective drug product In case the incidence...

SOP on Cleaning of Sampling Aids

1.0 Objective To lay down a procedure for Cleaning of Sampling Aids. 2.0 Scope This standard operating procedure is applicable for cleaning of sampling aids after sampling...

SOP on withdrawal, storage, observation & destruction of control/retention sample

1.0 Objective To lay down the procedure to withdrawal, storage, observation & destruction of control sample from production (Oral & Injectable), Q.C. (R.M. Retention). 2.0 Scope This...

SOP on Costumers Satisfaction

1.0 Objective To lay down a procedure for collecting views of the customers about the Sales Services of the company and also for obtaining suggestions...

SOP on Vendor Development, Qualification, De-qualification and Requalification for Raw Materials & Packing Material

1.0 Objective To lay down a procedure for the approval of vendors for raw & packing material and De-qualification and Requalification of existing approved vendors. 2.0...