SAT is an inspection at the user’s site after machine/instrument delivery. opposite to SAT, the Factory acceptance test is a Manufacturer site inspection by the user. site acceptance test in pharmaceuticals is done to verify the functioning, operation, and parameters along with manufacturere repersentative. Site Acceptance Protocol Site acceptance test protocol is prepared by the … Read more
Nonconformity finding in pharmaceuticals during Audit is a very crucial stage, where finding non-conformity becomes a hurdle for the organization. Nonconformity may be major or minor types it depends on what type of process is affecting at what level. What is Nonconformity As per ISO 19011 “Nonconformity” means non-fulfillment of a requirement, against ISO 9001 … Read more
The airlocks is a transition space that typically has two doors in series to separate controlled environments such as a cleanroom, lab, operating room, or isolation room from the corridor. What is an airlock? Airlocks are commonly used in the pharmaceutical industry to maintain cleanliness and prevent contamination of the manufacturing environment. In a pharmaceutical … Read more
Lead is a most undesirable impurity in pharma compounds and comes through the use of sulphuric acid, lead-lined apparatus, and glass bottles used for the storage of chemical materials so, we do a Limit Test for Lead to identify the acceptance level of lead in a sample. Limit test for lead Principle The limit test … Read more
The limit test for arsenic is based on the reduction of the arsenic in the arsenic state to the arsenic gas with zinc and hydrochloric acid. The arsenic gas stains the mercuric chloride paper yellow. The paper is dissolved in acid where the arsenic present as an impurity in the sample gets converted into arsenic … Read more
1.0 Objective: To lay down a procedure for the Operation and cleaning of Fluidized Bed Drier.2.0 Scope: This SOP is applicable to the Operation and cleaning of a Fluidized Bed Drier in the production area.3.0 Responsibility: Operator, Officer, Executive- Production DepartmentManager- Production Department 4.0 Procedure for Operation and Cleaning of Fluidized Bed Drier:4.1 Machine setting: … Read more
The Limit Test for Sulphate is designed to determine the allowable limit of Sulphate contained in a sample. Principle: The principle for the limit test of Sulphate is based on the reaction of soluble Sulphate with barium chloride in the presence of dilute hydrochloric acid to form barium Sulphate which appears as turbidity with a … Read more
A limit test for chloride is done to identify the impurity in the compounds by comparing the test solution against the standard solution. The chloride limits test is only designed to identify and control the impurity present in the compounds. Limit Test for Chloride Principle The limit test for chloride is based on the reaction … Read more
The limit test for iron refers to a type of analytical chemistry test used to determine the concentration of iron in a sample. This test is often performed in the laboratory as part of a larger suite of tests to determine the chemical composition of a substance.In a limit test for iron, a known volume … Read more
In pharmaceutical analysis, a limit test is a type of analytical test used to determine impurity in a substance whether a substance is present in a sample at a concentration above or below a specified limit. Limit tests are often used to ensure that a substance meets certain quality standards or regulatory requirements. Definition The … Read more
Objective: To initiate, incorporate, approve and record changes to the master documents. Scope: This Sop is applicable for changes to the master documents. Responsibility: All the functional Heads. Accountability: Head – Quality Assurance. Filling procedure for Document Change Control DCC No: Document change control number is entered, and DCC No., will be allotted using the … Read more
1.0 Objective: To lay down a procedure for status labeling in the production department.2.0 Scope: This procedure is applicable to the Status Labeling of equipment, cleaning and disinfectant aids, lubricating aids, in-process materials, and excess packing materials in the production areas.3.0 Responsibility: Officer, Executive – Production DepartmentManager – Production DepartmentQA Officer – In the process … Read more
Edge Runner Mill is widely used in industries till now, if talk about its usage centuries ago, the manual mortar and pestle was the traditional tool for accomplishing size reduction, and it is still frequently used on a modest basis. Compression size reduction may also be done on a small scale with end-runner mills and … Read more
1.0 Objective: To lay down a procedure for the operation of the Blister Pack Machine.2.0 Scope: This procedure is applicable to the operation of the Blister Pack Machine in the production area.3.0 Responsibility: Operator, Officer, Executive – Production DepartmentManager – Production Department 4.0 Procedure for Blister Pack Machine: 4.1 Ensure the area and equipment are … Read more
1.0 Purpose: To lay down the procedure for handling, investigating, and reporting of Out of Specification (OOS) results obtained during laboratory testing. This procedure provides guidance to assure that the investigations are conducted in a timely manner with appropriate depth and are supported by the necessary documentation to perform root cause analysis as appropriate. 2.0 … Read more
In today’s Pharmaceutical industries, the Granulation Technique is highly employed to get better Quality granules. Granulation is the act or process of forming or crystallizing into grains. Granules typically have a size range between 0.2 to 4.0 mm, depending on their subsequent use. Synonym “Agglomeration“: Agglomeration processes or, in a more general term, particle size … Read more