AHU Operational Qualification (OQ) Protocol Objective: The objective of this protocol is to verify that the AHU operates within defined parameters such as airflow, pressure, and filter integrity. 1.0 Protocol Approval: Signing this approval page confirms that the qualification approach described in this protocol is accepted. If any change becomes necessary, it will be handled … Read more
AHU Installation Qualification (IQ) Protocol Objective: The objective of this protocol is to verify that the AHU is installed as per approved design specifications, drawings, and manufacturer recommendations. This AHU Installation Qualification (IQ) Protocol covers the following: Related Topic: Learn Operational Qualification and Performance Qualification of AHU. SERIAL NO. ITEM DESCRIPTION 1.0 Identification and inspection … Read more
1.0 OBJECTIVE: To lay down the procedure for cleaning and operation of holding tank(capacity –3000 ltrs). 2.0 SCOPE: This procedure is applicable for cleaning and operation of holding tank (capacity –3000 ltrs) in Liquid department Pharmaceuticals. 3.0 RESPONSIBILITY:Operator, officer, executive – Production departmentManager- Production Department 4.0 DEFINITION(S)NA 5.0 PROCEDURE for Cleaning and Operation of Holding … Read more
Change Control system SOP, including preparation of Format, Numbering, Initiation, Change & Assessment by QA, Review, Approval, Implementation, Distribution, Retrieval, Annexures, and closing of change control. 1.0 OBJECTIVE: To lay down the procedure for Change Control system SOP. 2.0 SCOPE: This Change Control system SOP is applicable to all related user departments as specified in … Read more
1.0 OBJECTIVE: To lay down the procedure for Cleaning and operation of sparkle filter press. 2.0 SCOPE: This procedure is applicable for cleaning and operation of sparkle filter press in liquid department at Pharmaceuticals. 3.0 RESPONSIBILITYOperator, Officer, Executive- Production DepartmentOfficer, Executive- Quality Assurance DepartmentManager –Production and Quality Assurance Department. 4.0 DEFINITION(S)NA 5.0 PROCEDURE for Cleaning … Read more
1.0 OBJECTIVE: To lay down a procedure for cleaning and operation of carton over printing machine. 2.0 SCOPE: This procedure is applicable for cleaning and operation of carton overprinting machine in production department at Pharmaceuticals. 3.0 RESPONSIBILITYOperator, Officer, and Executive – Production DepartmentManager – Production Department 4.0 DEFINITION(S)NA 5.0 PROCEDURE: for Carton Over Printing Machine5.1 … Read more
1.0 OBJECTIVE: To lay down the procedure for cleaning and operation of linear bottle washingMachine 2.0 SCOPE: This procedure is applicable for cleaning and operation of linear bottle washing machine in Liquid department at Pharmaceutical. 3.0 RESPONSIBILITY:Operator, Officer, Executive- Production DepartmentOfficer, Executive- Quality Assurance DepartmentManager –Production and Quality Assurance Department. 4.0 DEFINITION(S):NA 5.0 PROCEDURE:5.1 Cleaning … Read more
1.0 OBJECTIVE: To lay down the procedure for cleaning and operation of manufacturing tank (capacity –1000 ltrs). 2.0 SCOPE: This procedure is applicable for cleaning and operation of manufacturing tank (capacity –1000 ltrs) at Liquid department in Pharmaceuticals. 3.0 RESPONSIBILITY:Operator, officer, executive – Production and QA departmentManager – Production and QA Department 4.0 DEFINITION(S)NA 5.0 … Read more
1.0 OBJECTIVE: To lay down the procedure for the Cleaning and Operation of leak test apparatus for filled bottles in Pharmaceutical lab. 2.0 SCOPE: This procedure is applicable to cleaning and operation of leak test apparatus, which is used for Leak test of filled bottles in liquid department at Pharmaceuticals. 3.0 RESPONSIBILITYOperator, Officer – Production … Read more
1.0 OBJECTIVE: Cleaning Validation Protocol for Multi Mill is designed to ensure that the cleaning procedure for multi mill removes residues to the extent of compliance with pre-determined acceptance level. 2.0 SCOPE: This protocol applies to Pharmaceutical Manufacturing Facility. 3.0 RESPONSIBILITY: It is a joint responsibility of Quality Control, Production, and Quality Assurance departments. The … Read more
1.0 OBJECTIVE: Cleaning Validation Protocol for Sifter to ensure that the cleaning procedure for Sifter removes residues to the extent of compliance with pre-determined acceptance level. 2.0 SCOPE: This protocol applies to Pharmaceutical Manufacturing Facility (name of company and place) 3.0 RESPONSIBILITY: It is a joint responsibility of Quality Control, Production and Quality Assurance departments. … Read more
Tablet presses or Compression machines are mechanical devices that compress granulated powders into uniform tablets for pharmaceuticals and other solid-dosage products. These machines force material between matching upper and lower punches seated in a die cavity to fuse it into a solid form. In operation, the lower punch first lowers into the die to create … Read more
The penetration of steam into all parts of the autoclave is essential for achieving and maintaining effective sterilization. The Bowie–Dick test is performed to verify adequate air removal and uniform steam penetration within a pre-vacuum steam autoclave, using a standardized Bowie–Dick test pack. During sterilization, air pockets and non-condensable gases may remain trapped inside the … Read more
Fumigation and fogging are commonly used in pharmaceuticals to control microbial contamination in controlled areas. Fumigation is a gaseous sterilization process that kills microorganisms and prevents microbial growth in the air or on surfaces such as walls and floors. Fumigation agents, such as formaldehyde and potassium permanganate, are often used to control microorganisms. This technique … Read more
Water is widely used in pharmaceuticals as an ingredient, solvent for processing, analytical reagent, and in the manufacturing of pharmaceutical products. So, according to pharmacopeia, different types of water are recommended as per the official book and chapter <1231>. Note: Information in this article doesn’t change the existing guidelines and regulations. It helps users understand … Read more
Sometimes, issues occur during the tablet manufacturing process; these are known as tablet manufacturing defects. Below is a detailed discussion of tablet manufacturing defects and their remedies, which helps in addressing these issues. To ensure and maintain product quality, tablets should be free from such visual defects. A pharmaceutical company that manufactures medicines may face … Read more