SOP for Preparation of Validation and Qualification protocols Objective : To lay down a procedure for Preparation of Validation and Qualification protocols applicable to all aspects of manufacturing processes, equipments, control systems (including computer hardware and software), utilities, facility, temperature mapping, Shipping and any significant changes to the above mentioned elements which may affect the … Read more

SOP for Access control system numbering and usage Objective : To lay down a procedure for assigning of identification numbers to access control system and usage of the system. Scope : This Standard Operating Procedure is applicable to various departments of formulation plant. Responsibility : Head-User department shall be responsible for sending the request to QA department … Read more

SOP for Code to Code Transfer of Materials and Additional Testing of Materials / Products Objective : To lay down a procedure for code transfer of same material from one code to another and to carry out additional testing of APIs, Excipients and Drug Products to comply with other specifications or Pharmacopoeia. Scope : This standard operating … Read more

SOP for Procedure for Operation of SAP system in Quality Assurance Department Objective : To lay down a procedure for Operation of SAP system for in Quality Assurance  Department. Scope : This SOP is applicable for production of the formulation plant. Responsibility : Head-QA/ Designee shall be responsible for releasing the Finished Goods as per this SOP. … Read more

SOP for Recording of Specimen Signatures Objective : To lay down a procedure for recording specimen signatures of all employees. Scope : This procedure is applicable for formulation plant. Responsibility : Head HRD or his/ her designee shall be responsible for recording specimen signatures before induction training is imparted to all newly recruited employees. HODs of … Read more

SOP for Repackaging / Re-labeling of Finished Goods Objective : To lay down a procedure for Repackaging / Re-labeling of Finished Goods. Scope : The scope of this standard operating procedure is applicable for Finished Goods which are either Returned or Existing Stocks; and marketed which are either received and kept in  Central Warehouse. Responsibility : Officer/Executive … Read more

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