The Area Qualification Protocol plays an important role in the pharmaceutical sector, serving as a vital process that ensures compliance and upholds quality standards across various sections within a pharmaceutical facility. This protocol entails a thorough assessment and examination of the important zone including cleanrooms, manufacturing areas, storage spaces, and laboratories to validate their appropriateness … Read more
The Site Master File is made with the objective to provide all site information like facility, process, Quality systems, and who’s who and to describe the firm’s general policy on Quality Assurance Systems and Documentation. It is designed to facilitate the various regulatory agents to have standard inspection and reporting systems. The Site Master File … Read more
Double Cone Blender equipment is used in pharmaceuticals to mix Excipients, chemicals, and cosmetics to get a homogeneous mixture of dry powders and granules. The principle of the double cone blender is based on the mechanical mixing that occurs due to tumbling motion. The double-cone blender is constructed by welding two cone-shaped sections at their … Read more
Batch manufacturing records (BMR) are an essential part of pharmaceutical manufacturing as they document the entire process of production and ensure that all steps have been performed correctly. Here are the preparation steps for BMR as per schedule M in pharmaceuticals: Steps for Batch Manufacturing Records Preparations: 1. Design the BMR format: The BMR should … Read more
1.0 OBJECTIVE: To lay down a procedure for online inspection of washed empty / filled/labeled bottles during Liquid Orals filling and packing operation. 2.0 SCOPE: This procedure is applicable for online inspection of washed empty / filled/labeled bottles of all the Liquid dosage forms in Pharmaceuticals. 3.0 RESPONSIBILITY: Operator, Officer, Executive – Production DepartmentManager – … Read more
There are various Autoclave Qualification Tests that need to be done along with procedure and acceptance criteria. Autoclave works by using heat and pressure to kill the microorganisms such as bacteria and spores so it becomes very crucial or very important equipment for sterilization processes In this article we will go through the few prerequisites … Read more
1.0 Purpose: To lay down a procedure for the preparation and approval of Bill of material (BOM).2.0 Applicable: This SOP is applicable for the preparation and approval of Bill of Material of different products manufactured at Pharmaceuticals.3.0 Responsibility:3.1 Designated person of Production shall be responsible for the preparation of bill of material for different products … Read more
1.0 Objective: To lay down a procedure for cleaning of shipper sealing machine.2.0 Scope: This procedure is applicable to the cleaning of the shipper sealing machine in the production area.3.0 Responsibility: Officer, Executive – Production DepartmentManager – Production Department 4.0 Procedure: 4.1 TYPE A:Change over from one batch to the next batch of the same … Read more
1.0 OBJECTIVE: To lay down a procedure for shift handover between the Shifts.2.0 SCOPE: This standard operating procedure is applicable for shift handover between the Shifts in the production department.3.0 RESPONSIBILITY: Officer, Executive Production for implementation of this Procedure.Manager Production for Overall compliance with this SOP. 4.0 PROCEDURE:4.1 The following are the instructions to be … Read more
1.0 Objective: To lay down a procedure for the operation of Bin Blender.2.0 Scope: This standard operating procedure Operation of Bin Blender is applicable to the Bin Blender located in the manufacturing area.3.0 Responsibility: Officer, Executive – Production Department follow procedure while executing the operationManager – Production Department for overall compliance 4.0 Procedure for Operation … Read more
1.0 OBJECTIVE: To lay down a procedure for cleaning of Strip Pack Machine.2.0 SCOPE: This procedure is applicable to the cleaning of strip pack machine in the3.0 RESPONSIBILITY: Operator, Officer, and Executive – Production DepartmentManager – Production Department 4.0 PROCEDURE :4.1 TYPE A Cleaning of Strip Pack MachineChange over from one batch to the next … Read more
1.0 Objective: To lay down the procedure for the operation and cleaning of the Index Type Rotary Bottle Washing Machine.2.0 Scope: This Standard Operating Procedure for Bottle Washing Machine is applicable for the operation and cleaning of the Index Type Rotary Bottle Washing Machine in the liquid Oral department.3.0 Responsibility:Production Executive, Production Officer. 4.0 Procedure:4.1 … Read more
1.0 Objective: To lay down the procedure for the Operation & Calibration of pH meter2.0 Scope: This sop of ph meter shall be applicable to the Analytical Development Department in Pharmaceuticals3.0 Reference: In-House4.0 Responsibility: Executive/Officer- Analytical Development5.0 Accountability: Manager-Analytical Development. 6.0 Procedure for pH meter, Make Lab India.:6.1 Cleaning Procedure for pH Meter:6.1.1 Clean the … Read more
Depyrogenation vs. sterilization these two terms may seem similar but, these are important processes/ methods used in industries such as pharmaceuticals and medical devices to ensure the safety and effectiveness of products. Let’s discuss one by one. What is Depyrogenation? The process of removal or inactivation of pyrogens from a product or surface is known … Read more
1.0 Objective: 1.1 To lay down the procedure for the Operation and Calibration of Dissolution Apparatus (Tester).2.0 Scope: 2.1 This SOP shall be applicable to the Analytical development at Pharmaceutical Analytical Lab.3.0 References: 3.1 In-House SOP of dissolution apparatus 4.0 Responsibility:4.1 AD Executive/Sr. Executive.4.2 To follow the procedure for calibration as per SOP.3.3 To maintain … Read more
1.0 Purpose: To lay down the procedure for the operation and cleaning of tunnel sterilizer.2.0 Aim: This Standard Operating Procedure is applicable for the operation and cleaning of depyrogenation tunnel installed in production.3.0 Responsibility:3.1 The line coordinators who are trained shall carry out the operation and cleaning process as per SOP.3.2 Officers/ sr. officers shall … Read more