Limit tests for heavy metals need not be confusing. This guide includes detailed protocols with equipment, reagent preparation and step-by-step instructions to perform a typical test procedure. For all of the Test A, B, C and D options, there are clear instructions to ensure your pharmaceutical quality control is accurate and on track. 1.0 Scope: … Read more
The solubility test is a basic test performed in the pharmaceutical laboratory to assess the solubility of a substance in a given solvent. This guide describes the entire solubility testing procedure, apparatus used, considerations for selection of solvents, temperature, and standard solubility classification from very soluble to practically insoluble. This step-by-step reference will help you to test accurately and fulfil the pharmaceutical quality requirements.
The Capreomycin Sulphate Colour of Solution Test is an important quality control test to check the appearance of a prepared capreomycin solution. This test is performed to ensure the solution meets the pharmacopoeial colour standards, which indicates that the product is of good quality and consistent.
This article describes the SOP for preparation and standardization of 0.1M ethanolic sodium hydroxide solution. It includes apparatus, reagents, preparation of the thymolphthalein indicator, preparation of sodium hydroxide solution, standardization procedure of benzoic acid, formula to calculate the molarity, storage conditions and reference as per IP norms. It is a guide for pharmaceutical quality control and analytical laboratories.
As one of the major pharmaceutical manufacturing cities of India, Ahmedabad has multinational companies like Zydus Lifesciences, Torrent Pharmaceuticals, Cadila Pharmaceuticals and Intas Pharmaceuticals. The companies are producers of generics, biosimilars, vaccines, injectables and APIs with the facilities located at Sanand, Moraiya, Changodar and Bavla (PHARMEZ) industrial estates. Working in tandem with the pharmaceutical ecosystem … Read more
Download the SOP for Additional Packing Material in pharmaceutical manufacturing. Learn the GMP-compliant procedure for requesting, issuing, approving, and reconciling extra packaging materials
Learn the differences between primary, secondary, and tertiary pharmaceutical packaging materials with practical examples of bottles, blister packs, cartons, vials, shippers, and pallets used in the pharma industry.
IND, or the Investigational New Drug Application, is a U.S. permission process required to move any new medicine or therapy from laboratory research to human testing, meaning clinical trials. For example, imagine scientists have developed a new medicine. They cannot directly test it on humans. First, they must submit proof to the U.S. drug authority through an … Read more
Self-inspection, also known as an internal audit, is a routine check that pharmaceutical companies run on their own to check the gaps between the procedures and documents. All manufacturing and quality teams must follow this process to maintain compliance. We can say it is a review that checks if daily work matches Good Manufacturing Practices … Read more
1.0 Scope: Procedure is applicable to perform the colour test of the sample wherever specified. Learn: Procedure to Check Clarity of Sample Solution 2.0 Apparatus:You will need: 3.0 Reagents:Use analytical grade (AR) chemicals for the following: 4.0 Method: A. Ferric Chloride Colorimetric Solution (FCS) Dissolve roughly 55 g of ferric chloride hexahydrate in a mixture … Read more
1.0 Scope: This procedure is applicable to check the clarity of sample solution. Learn: Laboratory Color Test Procedure 2.0 Apparatus: 3.0 Reagents: 4.0 Method:4.1 Preparation of Standard Suspension:First, take 1.0 g of hydrazine sulphate. Dissolve it in enough purified water to make exactly 100.0 ml. Leave the mixture aside for about 6 hours. Next, take … Read more
1.0 Purpose: To describe the method for dispensing of active raw material from mother bottle to baby bottle as per requirement. 2.0 Aim: This Standard Operating Procedure is applicable to the distribution of active raw material supplied by approved vendor from mother bottle to small sterile bottles as required for formulation of a batch at … Read more
1.0 OBJECTIVE: To lay down the procedure for operation of Automatic Filling and Sealing Machine. 2.0 SCOPE: This procedure is applicable for operation of Automatic Filling and Sealing Machine in liquid department. 3.0 RESPONSIBILITY: 3.1 Operator / Production Staff To operate the equipment/machine as per approved SOP.To clean the equipment after use and keep the … Read more
1.0 OBJECTIVE: To lay down a procedure for cleaning of vacuum cleaner. 2.0 SCOPE: This procedure is applicable to cleaning of vacuum cleaner used in production department in the Pharmaceuticals. 3.0 RESPONSIBILITY:Operator, Officer, Executive – Production DepartmentManager – Production Department 4.0 DEFINITION(S):NA 5.0 PROCEDURE: 5.1 Ensure that the power supply is turned off.5.2 Transfer the … Read more
1.0 OBJECTIVE: To lay down the procedure for operation and maintenance of DM water plant. 2.0 SCOPE: This procedure applies to DM water plant in Pharmaceuticals. 3.0 RESPONSIBILITY: Production In-Charge, Maintenance personnel, Maintenance Engineer. Learn: SOP for Preventive Maintenance of DM Plant 4.0 PROCEDURE for DM Water Plant: 4.1 PLANT SPECIFICATIONS:Maximum flow rate: 1.2 m3 … Read more
AHU Performance Qualification (PQ) Protocol Objective: The objective of this protocol is to verify that the AHU consistently maintains required environmental conditions during routine operation. Learn the Previous Steps of AHU Qualification: Installation Qualification Protocol for AHUOperation Qualification Protocol for AHU 1.0 PROTOCOL APPROVAL: Submitting this page for Protocol No. is acceptance of the Appendix … Read more