Saturday, November 18, 2017

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...

SOP on Internal Audit and Self Inspection

1.0 Objective To lay down a procedure for periodic internal audit and self-inspection to ensure current Good Manufacturing practices compliance. 2.0 Scope This Standard Operating Procedure is...

SOP on Date and Time Format in Written Procedures

1.0 Objective To lay down a procedure for entering the date and time in all written procedures 2.0 Scope This Standard Operating Procedure is applicable to...