SOP on Preparation & Handling of Un-blinding Envelopes 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. Scope : This standard operating procedure is applicable for formulation plants. Preparation of un-blinding envelopes shall involve the following Procurement of packaging material required for … Read more
SOP on Management of Clinical Supplies Objective : To lay down a procedure for the management of the clinical supplies of the pharmaceutical products. Scope : This standard operating procedure is applicable for formulation plant. Management of Clinical Supplies shall involve the following: Procurement of reference drug. Unpacking and repacking of reference drug. Manufacturing and packing of … Read more
SOP on Artwork Design and Approval Objective : To lay down a procedure for artwork design and approval (of Printed packaging materials). Scope : This Standard Operating Procedure is applicable to all drug products manufactured and marketed. Responsibility For Artwork development and approval system of Export markets Head Marketing/Business Development shall be responsible for providing the Packaging … Read more
SOP on Utilization of Biaxially Oriented Polypropylene (BOPP) Tapes Objective : To lay down a procedure for the selection of different colours of Biaxially Oriented Polypropylene (BOPP) tapes and their usage. Scope : This Standard Operating Procedure is applicable to drug products (formulations) manufactured or marketed. Responsibility : Officer / Executive – Packaging Development shall be responsible for … Read more
SOP On Quality Management Objective : To lay down a procedure for Quality Management . Scope : This procedure is applicable for all formulation plants. Responsibility : Head Quality Assurance shall be responsible for compliance of this SOP. Heads of Production, QC, Stores, Engineering, Administration, HR, Materials Management, Regulatory Affairs, etc. shall be responsible for implementation and compliance … Read more
SOP on Corrective and Preventive Action (CAPA) Objective : To lay down a procedure to operate as a single control point for the Corrective and Preventive Action so as to eliminate the causes of potential non-conformities and / or encountered non-conformities in order to prevent their occurrence and / or recurrence. Scope : This Standard Operating Procedure … Read more
SOP on Date and Time Format in Written Procedures Objective : To lay down a procedure for entering the date and time in all written procedures. Scope : This Standard Operating Procedure is applicable to all operational documents applicable at all pharmaceutical formulation plants / Operations. Responsibility : All concerned HODs shall be responsible for implementation of this … Read more
SOP on Document and Data Control Objective : To lay down a procedure for control of Documents and Documented Data. Scope : This Standard Operating Procedure is applicable for the control of documents and documented data of all the formulation plants/ operations. Responsibility : All HODs shall be responsible to follow this SOP for maintaining control on … Read more
SOP on Assessment of Contract Analytical Laboratory for Qualification Objective : To lay down a procedure for Assessment of Contract Analytical Laboratory for qualification. Scope : This Standard Operating Procedure is applicable for qualification of Contract Analytical Laboratory for analysis of samples for which in-house testing facility is not available. Responsibility : Heads of Quality Control and Quality … Read more
SOP on Assigning of Numbers for Qualification Documents, Protocols and Reports Objective : To lay down a procedure for assigning of number for qualification documents, protocols and reports. Scope : This Standard Operating Procedure is applicable for assigning of number for various qualification documents, protocols (validation protocols, various study protocols like stability studies, etc.) and the … Read more