The following ICH (Q1A, R2, and Q1B step 5) and FDA guidance explain the accelerated stability testing and their studies. It is important to conduct stability studies to guarantee good quality, safety, and efficacy of drugs throughout their lifecycle which must be satisfied before any pharmaceutical product can be accepted or approved. These accelerated stability … Read more
Learn About Standard Operating Procedures for Daily Verification of Weighing balance along with their, Purpose, Scope, Responsibility, Precautions, Procedure, Operation, and Tolerance limit. 1.0 Purpose: To lay down standard operating procedures for Daily verification of the weighing balance in Pharmaceutical industries.2.0 Scope: This Daily Verification of Weighing balance is applicable for all the weighing balances used in … Read more
By definition, Weighing balance calibration is a process of verifying the accuracy and precision of a weighing balance used in pharmaceutical manufacturing. It involves comparing the measurement of the balance to a known standard to ensure that it is providing accurate results. In the pharmaceutical industry, we perform monthly calibration on weighing balances to verify … Read more
Learn about the Standard Operating Procedures for the induction cap sealer machine, including their scope, responsibilities, precautions, procedures, and operation. 1.0 Scope: This SOP is applicable to setting and operating an induction cap sealer machine in the tablet department. 2.0 Responsibility: 2.1 Officer production is responsible for the implementation of this SOP2.2 Head production is responsible for ensuring the … Read more
After completing the Design Specification and Design Qualification for new equipment, a user inspection is typically conducted before the delivery to the site. This inspection is referred to as the Factory Acceptance Test (FAT). The manufacturer of a machine will prepare the FAT protocol based on the Design Qualification, as per the built machine specification, … Read more
A Design Qualification comes to the role after the Design Specification as well as User requirements specification are finalized. Once URS is finalized follow the given specification requirement in the purchase order (PO). After checking it properly, the engineering, and production department will prepare the design qualification, which includes drawing, calculation, symbols, and other design … Read more
User requirement specification (URS) is a list of all the equipment-related requirements from the user, The list shall be prepared based on the types of equipment to be purchased. After the preparation of the list, the URS documents are sent to the manufacturer to get the required materials as per the given criteria. The user department … Read more
In the pharmaceutical industry, it’s essential to have sufficient lux or light intensity for carrying out work accurately. If the work area lacks proper illumination, it can lead to issues such as eye strain and fatigue, especially during detailed work. Excessive lighting is also unnecessary, as it may result in glare and dazzle. According to … Read more
These days, choosing the right material for constructing manufacturing equipment parts is an important aspect. Manufacturing equipment is usually made of stainless steel, with various alloys in SS such as 304, 316, and 316L. These alloys are widely used and valuable. Type 304 is a commonly used alloy in the group of steel known as … Read more
Before starting to pack any product, the Production officer and Q.A. officer should check the area based on the line clearance checklist mentioned in the BMR/BPR records. While conducting line clearance, make sure to follow all points to ensure product quality and prevent contamination, mix-up, and cross-contamination. Line Clearance Checklist point for Primary Area: Related … Read more
Autoclave validation is required to get effective Sterilization to ensure good product quality and also sterility of glassware and media used for analysis is very important for product manufacturing. Ineffective autoclave validation may cause deviation in sterility and it may lead to a false result. So data loggers play a very important role in recording the … Read more
Learn about the Standard operating procedure for “Entry and Exit Procedure in Pharmacautical” along with Purpose, Scope, Responsibility, Instruction, Procedure, Entry procedure for employees, Exit procedure for the employees, and Entry and Exit procedure for visitors. 1.0 Purposes: 1.1 Lay down the standard operating procedure for the entry-exit procedure in pharmaceuticals. 2.0 scope: 2.1 This SOP applies to all personnel, … Read more
In pharmaceutical industries AHU and HVAC play an essential role in controlling microorganism-free environments by supplying fresh air. The quality of pharmaceutical products is dependent on hygiene within the industry. Preventing the spread of microorganisms through the air is highly significant. Whether it’s during laboratory development or manufacturing activities, maintaining a clean and suitable room atmosphere is … Read more
A Rapid mixture granulator (RMG) is used in mixing, agitation, and shear mixing (to break internal molecular force). It is used in pharmaceuticals to make granules. The components of the RMG (impeller and chopper) are highly responsible for the wet granulation process. Components of RMG: Rapid mixture granulator components are as follows: The impeller and chopper are responsible … Read more
Multimill is used widely in pharmaceuticals (granulation section), cosmetics, chemicals, and bulk drugs for cutting granules into small particle sizes by using cutting, Pulverization, and hammering mechanisms. Components of multi-mill: 1. Hopper inlet The hopper is used to feed products to the mill. 2. Milling chamber The milling chamber contains a screen to reduce particle … Read more
1.0 Purpose: To lay down the standard operating procedures for the Collection and Disposal of product waste.2.0 Scope: This scope is applicable to all the product waste generated during the following activities. 3.0 Responsibility:3.1 Officer concerned department is responsible for the Product Waste; Collection and Disposal.3.2 All concerned heads of the department and head of Quality Assurance are … Read more