Learn about the Installation Qualification Protocol for Blister Packing Machine along with Annexures. The purpose of this protocol is to establish documentary evidence to ensure that the Blister packing machine received matches the Design specification and also to ensure that it is properly and safely installed. Serial No. Item Description 1.0 PROTOCOL APPROVAL 2.0 OVERVIEW: 2.1 … Read more
There are many pharmaceutical manufacturing companies in India, but only a few are leading in the manufacturing and marketing of pharmaceutical products. We have prepared a list of India’s top 10 pharmaceutical manufacturing companies in 2024 according to recent data obtained from different sources. The list is based on their current growth with their regulatory approval and … Read more
Qualification refers to activities undertaken to demonstrate that utility and equipment are suitable for their intended use and performing properly. Qualification Definition: It is the action of providing and documenting that equipment or ancillary systems are properly installed, work correctly, and accurately leading to the expected results. Qualification is a part of validation but individual … Read more
Differential pressure in pharmaceuticals helps to prevent contamination and cross-contamination. A Magnehelic gauge device is used to measure the pressure difference between the two adjacent sections. The gauge has two inlets point for the pressure that is connected to the area being monitored. Differential pressure is the pressure that differentiates between the pressure of the atmosphere of … Read more
A Dissolution Test is used for in vitro Testing of the Tablets and Capsules. Dissolution provides the product Release info to know the drug delivery. Dissolution apparatus are used throughout the product development life cycle, from Product release to stability testing and study of the product data from product to product. Then after passing or approval from the … Read more
The purpose of the Blender Installation Qualification protocol is to establish documentary evidence to ensure that the Pillar Type Blender system received matches the Design specification and also to ensure that it is properly and safely installed. The equipment shall be used for blending different granules/powders to be used in the formulation. The equipment shall … Read more
The aim of developing the Operational Qualification Protocol of Pillar Type Blender is to collect enough details about the Pillar Type Blender. We want to set out the conditions needed for this machine and ensure that everything it does matches what it was designed for. We also want to ensure that the limits mentioned in … Read more
The objective of developing and executing the Blender Performance Qualification protocol is to document the verification of all aspects of the equipment that can affect product quality. To make an impact assessment of the critical components of the equipment on the material to establish, check, and document the performance of equipment in the established/predetermined operating … Read more
The purpose of the Auto Coater Operational Qualification protocol is to establish the documentary evidence to ensure that the installed Auto Coater shall operate reproducibly and consistently within its full dynamic range of operation according to the manufacturer’s specifications. SERIAL NO. ITEM DESCRIPTION 1.0 PROTOCOL APPROVAL 2.0 OVERVIEW: 2.1 Objective 2.2 Purpose 2.3 Scope 2.4 … Read more
The purpose of the Auto Coater Performance Qualification protocol is to verify that the equipment produces the desired output. Once the equipment is installed and Operational qualification is done, we shall plan to check its performance. The equipment’s working capacity is challenged by charging the equipment with the maximum and minimum capacity of the equipment. … Read more
Below learn about the List of Stamps, Colors and Types of Document Copies (Master, Controlled, and Obsolete Copy) and the difference between Controlled documents and uncontrolled Documents used in the Pharmaceutical documents system. Types of Document Copies in Pharmaceuticals: Master Documents: The originally approved copy of a document Is marked as a “MASTER COPY” stamp … Read more
Standard working procedure for estimation of Nickel / Standard Working procedure for Nikel estimation by using AAS Methods. Principle: The Nickel content in the sample is determined by aspirating the sample into the flame of an Atomic Absorption Spectrophotometer after pre-concentration. Measured the Absorbance at 232 nm using a Nickel Hollow Cathode Lamp. Limit of … Read more
Standard operating/ Working procedure for Estimation of Sodium, Physical and chemical methods of sampling and test for water and wastewater: Part 45 Sodium Principle: When a sodium-containing solution is put into a flame, the brightness of the light passing through it will decrease depending on how much sodium is in the solution. A special lamp … Read more
Standard Operating procedure for estimation of BORON in Pharmaceutical and scientific labs. Principle: When Azomethine-H, which comes from condensation of H Acid (8-amino-naptha-1-ol-3.6-disulphonic Acid) and Salicyladehyde, reacts with borate in a watery solution with a pH higher than 6, it a yellow complex that we can measure using a spectrophotometer. To understand the yellow complex … Read more
Preparation and Standardization of 0.01 M Sodium Tetraphenylborate (C6H5)4BNa) solution and calculating formula in Pharmaceutical labs. Name: 0.01 M Sodium Tetraphenylborate (C6H5)4BNa) Reagents: Sodium TetraphenylborateSodium HydroxideAluminium HydroxideSodium ChlorideCetylpyridinium ChloridePotassium Chloride Method of Preparation: Method of Standardization: Calculation: The calculation formula is : Where ‘a’ is the volume of 0.005 M cetylpyridinium chloride required without potassium … Read more
Preparation and Standardization of 0.1 M Tetrabutylammonium Hydroxide (C16H37NO) Solution in Pharmaceutical Labs. Name: 0.1 M Tetrabutylammonium Hydroxide (C16H37NO) Reagents : Preparation of 0.1 M Tetrabutylammonium Hydroxide: Method of Standardization: Storage: Store below 25°C & store in an amber-colored bottle. Protect exposure from CO2 & water. Shelf life: The shelf life of the above solution … Read more