Aim: The aim is to find out the normality of the given 0.1 M Ceric ammonium Sulphate. Requirements: Equipment: A special tube with a tap, a cone-shaped flask, and a small tube.Reagents: Ceric ammonium sulphate, Sulphuric acid, Arsenic trioxide, Sodium hydroxide, and some more sulphuric acid. Principle: We test Ceric ammonium sulphate by mixing it … Read more
There is a provision of guidelines for storage, sales, precriptions and classififcation of each drugs Under the differernt schedules of Drugs and Cosmetic rules 1945. Below is the List of Drugs under Schedule C, C1, G, H, H1, K, P, M, N and X with CAUTION and WARNING. Drugs SCHEDULE ‘C’ SCHEDULE ‘C(1)’ Drugs SCHEDULE … Read more
1.0 Purpose: To describe the procedure for monitoring and recording critical environmental parameters of different classes at the production facility. 2.0 Aim: This Standard Operating Procedure is applicable for monitoring and Recording Critical Environmental Parameters such as temperature, relative humidity, pressure differential, and non-viable particle count of a different class (class A, B, C, and … Read more
Pharmaceutical Aids Definition: The elements having little or no therapeutic value, but are basically used in the production or compounding of various pharmaceutical dosage forms are known as pharmaceutical aids. In this article, we will explore the definition, types, importance, benefits, challenges, safety considerations, and regulations. Role of Pharmaceutical Aids Pharmaceutical aids play a critical … Read more
The term “organoleptic” refers to the ability to perceive and evaluate sensory properties through our sensory organs, such as taste, smell, texture, and color. In Pharmaceutical drug manufacturing, organoleptic agents are added to pharmaceutical formulations to enhance their sensory qualities to improve patient acceptability. In other words, Organoleptic agents in pharmaceutical aids are the components … Read more
Standard Operating Procedure for Estimating Mercury 1.0 Purpose: To lay down the procedure for the Estimation of Mercury using Atomic Absorption Spectroscopy. 2.0 Aim: This Standard Operating procedure is applicable to the Estimation of Mercury using Atomic Absorption Spectroscopy (AAS) in a Pharmaceutical Laboratory. Principle: The method used here, called flameless AAS (Atomic Absorption Spectroscopy), … Read more
Understand and Differentiate them FDA Form 483 and Warning Letters: FDA Form 483 is like a detailed report card that talks about what people saw when they visited the manufacturing site. These people work for the FDA, and they write down everything they notice in a special order based on how important it is. Each … Read more
Standard operating procedure for Microbiological Testing of In-Process Packing Material, SOP for Bioburden Test. I.0 Purpose: This SOP outlines the steps for conducting Microbiological Testing of In-Process Packing Material. 2.0 Scope: This SOP is applicable for the Microbiological Testing of In-Process Packing Material. 3.0 Responsibilities: All Quality Control personnel are responsible for adhering to and … Read more
Standard Operating Procedure for Operating and Validating Anaerobic Systems in Pharmaceutical Microbiology Laboratory. 1.0 Purpose: This document outlines the step-by-step procedure for operating and Validating Anaerobic Systems. 2.0 Scope: This SOP pertains to the operation and validation of the Anaerobic System Mark III (Hi-Media) within the Microbiology Department. 3.0 Responsibilities: Microbiologist: Responsible for implementation of … Read more
Testing Method for Checking MOC of SS Material (Molybdenum Test): Equipment used in the pharmaceutical industry is mainly crafted from special types of Stainless Steel. The primary reason for using this metal is that it works well with most manufacturing methods. The medicine must contain only the components specified in the approved formula. When we … Read more
1.0 Objective: The Purpose of this SOP is to lay down the procedure for the Operation and cleaning of the Domino Thermal Inkjet Printer. 2.0 Scope: This SOP is applicable for the Operation and Cleaning of the Domino Thermal Inkjet Printer at the manufacturing facility in Pharmaceuticals. 3.0 Responsibility:3.1 Operator Production shall be responsible for … Read more
1.0 Objective: The purpose of this SOP is to lay down the procedure for the Carton 2D Barcode Printing Machine. 2.0 Scope: This SOP is applicable for the Operation of a Carton 2D Barcode Printing Machine in a Manufacturing facility in Pharmaceuticals. 3.0 Responsibility:3.1 Operator Production shall be responsible for the operation of the Carton … Read more
Automatic Cartoning Machine is used for Packing blisters/Strips inside the carton in secondary packing areas in Pharmaceuticals. 1.0 Purpose: The purpose of this standard operating procedure is to lay down the procedure for Operation and Cleaning of Automatic Cartoning Machine (CP-150). 2.0 Scope: This SOP is applicable to the Operation and Cleaning of an Automatic … Read more
Standard Operating Procedure for Operating and Validating a Biosafety Cabinet 1.0 Objective: The purpose of this procedure is to outline how to use and verify the functionality of a Biosafety Cabinet. 2.0 Scope: This procedure covers the usage and internal validation of a Biosafety Cabinet. 3.0 Responsibilities: Microbiologist: Responsible for using, validating, and maintaining the … Read more
Standard Operating Procedure for Operating and Cleaning a Vortex Mixer in the Microbiology Department. I.0 Purpose: The purpose of this SOP is to provide guidelines for the proper operation and cleaning of the Vortex mixer. 2.0 Scope: This procedure applies to the Microbiology section of the Quality Control Department. 3.0 Responsibilities: 3.1 Quality Control Department … Read more
The Antibiotic Zone Reader quickly and accurately helps figure out how strong antibiotics are by measuring the size of the zone where bacteria can’t grow in a Petri dish. 1.0 Objective: The objective of this Standard Operating Procedure is to provide a written procedure for the operation and calibration of the Antibiotic Zone Reader. 2.0 … Read more