Standard Operating Procedure (SOP) for Milli Q Water purification system for its operation, and general maintenance procedure. SOP for Milli Q Water System 1.0   PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the operation and maintenance procedure of the Milli Q Water System. 2.0   SCOPE – SOP for Milli Q Water […]

Standard Operating Procedure (SOP) for Work Permit System in Pharmaceutical drug manufacturing plant. The work permit system is a formal written procedure used to control the hazards in non-routine work. The different work permit highlights the relevant hazards and precaution to be taken for the respective work before starting the activity. Procedure for Work Permit […]

Standard Operating Procedure for Environment, Health & Safety (EHS) Policy and procedure/practices at pharmaceutical drug manufacturing plants. Procedure / Policy: Environment, Health & Safety (EHS) 1.0   PURPOSE: The objective of the procedure is to define the company goal and driven procedures with respect to the top management. Establish the Environment, Health & Safety Management System […]

The Standard Operating Procedure (SOP) to describe the various aspect of Industrial Hygiene in pharmaceutical drug manufacturing plants. Industrial Hygiene – The science devoted to the anticipation, recognition, evaluation, prevention, and control of those occupational factors or stresses arising in or from the workplace which may cause sickness, impaired health and well being, or significant […]

Standard Operating Procedure (SOP) for Physical and Logical Control Policy of Computer system to fulfill the requirement of 21CFR Part 11 under the cGMP activity in the pharmaceutical drug manufacturing unit. Computer System Control Policy 1.0   Purpose: To define the process of the physical and logical security policy of the computer system. 2.0   Scope: This […]

Standard Operating Procedure (SOP) for Entry and Exit Procedure in Quality Control (QC) Laboratory in a pharmaceutical plant. Entry and Exit Procedure in QC Lab 1.0   PURPOSE: The purpose of this SOP is to laydown the entry and exit procedure for Quality Control (QC) Laboratory area. 2.0   SCOPE: This procedure shall be applicable to the […]

Standard Operating Procedure (SOP) for the operation of 1010 KVA Diesel Generating – DG Set installed for power backup in the pharmaceutical drug manufacturing plant. Procedure for Operating of 1010 KVA DG Set 1.0   PURPOSE: The purpose of this SOP is to define the procedure for the operation of the 1010 KVA DG set. 2.0  […]

Standard Operating Procedure (SOP) for Raw Material Reconciliation in the warehouse/store department in pharmaceuticals to maintain the stock of raw material.  Procedure for Raw Material Reconciliation 1.0   PURPOSE: The purpose of this SOP is to define the procedure for raw material reconciliation. 2.0   SCOPE: This procedure is applicable to all raw materials for verification of […]

Standard Operating Procedure (SOP) for sampling from different points and microbiological analysis/testing of Purified water samples in pharmaceutical plants. Sampling and Testing of Purified Water in Microbiology 1.0   PURPOSE: To lay down the procedure for Sampling and Testing of Purified Water. 2.0   SCOPE: This Standard Operating Procedure is applicable to the Microbiology Department. 3.0   REFERENCE: […]

Standard Operating Procedure (SOP) for Analyst/Chemist Qualification, Data Reviewer Qualification through performing parallel Analysis, and other evaluation parameters.  Procedure of Analyst / Reviewer Qualification 1.0   PURPOSE: The purpose of this SOP  is to describe the procedure for analyst/reviewer qualification. 2.0   SCOPE: The SOP is applicable for analyst/reviewer qualification in the Quality Control department at the […]

Standard Operating System (SOP) for Operation of Waters High-Performance Liquid Chromatography (HPLC) system. This procedure applies to the Waters – Alliance HPLC system. SOP for Waters HPLC System 1.0   Purpose : This SOP is to describe the operation procedure of the High-Performance Liquid Chromatographic (HPLC) system (Make-Waters, Model-Alliance) in the Quality Control Department. 2.0   Scope: […]

Standard Operating Procedure (SOP) for preparation, review, approval, issuance, maintenance, and archival of controlled Master Batch Record (MBR) throughout the product lifecycle to meet and maintain sustainable compliance to current Good Manufacturing Practices (cGMPs). SOP for Master Batch Record (MBR) 1.0   PURPOSE: The purpose of this procedure is to establish uniform requirements and guidelines utilizing […]

Standard Operating Practices (SOP) for the receipt, checking, passivation, storage, and disposal (handling) of Sieves/Screens. Procedure for Handling of Sieves and Screens 1.0   PURPOSE: The purpose of this SOP is to lay down the procedure for inspection & handling of Sieves and Screens. 2.0   SCOPE: This SOP is applicable to the receipt, checking, numbering, passivation, […]

Standard Operating Procedure (SOP/Guideline) for Packing of Drug Product. General rules to be adopted in the packing section for maintaining product identity, eliminating the potential mix-ups, handling of rejection, and smooth operation of the packing department. Guideline for Drug Product Packing 1.0   PURPOSE: The purpose of this SOP is to lay down general rules (to […]

Standard Operating Procedure (SOP) for Entry and Exit in the primary area of production at the pharmaceutical drug manufacturing plant. Procedure for Entry and Exit in the Primary Area 1.0   PURPOSE: The purpose of this SOP is to laydown the entry and exit procedure in the Primary Area of the production department at the pharmaceutical […]