SOP for Destruction of Placebo Batches Objective : To lay down a procedure for Destruction of Placebo Batches (Analytical/Clinical). Scope : This Standard Operating Procedure is applicable for formulation plant. Responsibility : Executive/ Manager – Production shall plan the destruction of Placebo batches after consultation with Quality control, PDL, R&D ,Stores and Quality Assurance. Head- Stores/ Production/QC/QA … Read more

SOP on Cleaning Program Objective : To lay down a procedure for cleaning program. Scope : This procedure is applicable in all departments of formulation plant. Responsibility : Officer/ Executive-Concerned department shall be responsible for implementation of this SOP. Head-QA shall be responsible for compliance of this SOP. Abbreviations and Definitions Critical Equipments    :  Equipments that … Read more

SOP for Handling of Yield Non-conformance Objective : To lay down a procedure for handling of yield non-conformances. Scope : This standard operating procedure is applicable for formulation plant. This SOP is applicable for those batches in which the yield obtained is less/more than the expected yield. Responsibility : Supervisor / Manager-Production shall be responsible for … Read more

SOP for Cleaning Procedure for Sampling Aids Objective :  To lay down a procedure for Cleaning of Sampling Aids. Scope :  This standard operating procedure is applicable for formulation plant. Responsibility : Trained Worker shall be responsible for cleaning of Sampling Aids. Executive /Officer IPQA shall be responsible for the Implementation of this SOP. Head-QA … Read more

SOP on Issuance and Control of Formats /Records / Log Books. Objective : To lay down a procedure for issuance and control of Records/ Formats / Log Books. Scope : This standard operating procedure is applicable for Formulation Plant. Responsibility Manager User department or his / her designee shall be responsible for giving the request for issuance … Read more

SOP on Blinding and Re-labeling of Clinical Trial Samples for Clinical Trial purpose Objective : To lay down procedure for blinding and re-labeling of Clinical Trial samples for blinded Clinical Studies of the drug products. Scope : This standard operating procedure is applicable for formulation plant. The procedure is applicable for blinding and re-labeling of clinical … Read more

SOP on Analytical Requisition Numbering Procedure for In-process, Finished Product and Wash Water Sample Objective : To lay down a procedure for analytical requisition numbering system for in-process, finished product and wash water sample. Scope : This standard operating procedure is applicable for assigning analytical requisition number to in-process, finished product and wash water sample … Read more

SOP on Planning and Handling of Exhibit batches and Placebo batches Objective : To lay down a procedure for Planning and Handling of Exhibit batches and Placebo Batches. Scope : This Standard Operating Procedure is applicable for formulation plant. Responsibility : Executive / Supervisor – Production and PDL personnel shall plan the manufacture of Exhibit batches and … Read more

SOP on Procedure for Procurement, Handling, Storage and Reconciliation of LDPE Poly Bags and Hand Gloves Objective :  To lay down a procedure for Procurement, Handling, Storage and Reconciliation of LDPE Poly Bags and Hand Gloves. Scope :  This SOP is applicable for Formulation Plant. Responsibility : Production Supervisor / Officer shall be responsible for the … Read more

SOP on Batch Numbering procedure for Optimization /Exhibit Batches of Drug Products and Intermediates Objective : To lay down a procedure on the batch numbering system for optimization/exhibit batches of drug products and intermediates. Scope : This standard operating procedure is applicable for assigning the batch number to optimization/exhibit batches and intermediate products to be manufactured. … Read more