SOP for Recording observations in Batch manufacturing records Objective : To lay down a procedure for recording observations in a Batch Manufacturing Record. Scope : This Standard Operating Procedure is applicable for all the products being manufactured by Formulation Plant. Responsibility : Officer / Executive – Production shall be responsible for recording the observations and calculation’s in … Read more
SOP for Handling of Incidents Objective : To lay down a procedure for handling of incidents. Scope : This Standard Operating Procedure is applicable for formulation plant. Responsibility Executive / Supervisor of concerned department shall be responsible for performing the technical evaluation and mitigation of incidents as per this SOP. Officer / Executive QA shall be responsible … Read more
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