2021

Sterile Product Building, Facility and Clean Area Classification Guideline By USFDA

Aseptic Processing Guidelines

Sterile Product Building, Facility and  Clean Area Classification Guideline By USFDA has clearly mentioned what conditions to be followed to maintain the Sterile Conditions in Sterile Product Manufacturing site. 21 CFR 211.42(b) states, in part, that “The flow of components, drug product containers, closures, labeling, in-process materials, and drug products through the building or buildings […]

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TEST FOR SPECIFIED MICRO-ORGANISMS (Ph. Eur. method 2.6.13.)

Microbiology

TEST FOR SPECIFIED MICRO-ORGANISMS (Ph. Eur. method 2.6.13.) INTRODUCTION The tests described hereafter will allow determination of the absence or limited occurrence of specified micro-organisms that may be detected under the conditions described. The tests are designed primarily to determine whether a substance or preparation complies with an established specification for microbiological quality. When used

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SOP For Operation, Maintenance And Calibration Of Ultrasonic Water Bath

Quality Control

The purpose of this Standard Operating Procedure (SOP) is to lay down the procedure for Operation, maintenance and Calibration of Ultrasonic Water Bath. PROCEDURE: PRELIMINARY CHECK: Fill the Water bath with water up to height of minimum 7cm from bottom of tank. Whenever the Ultrasonic Water Bath is required with specific temperature then heater to

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Sterile Drug Products Produced by Aseptic Processing – USFDA Guideline for Buildings & Facilities

USFDA Guidelines

21 CFR 211.42(b) states, in part, that “The flow of components, drug product containers, closures, labeling, in-process materials, and drug products through the building or buildings shall be designed to prevent contamination.”21 CFR 211.42(c) states, in part, that “Operations shall be performed within specifically defined areas of adequate size. There shall be separate or defined

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EU Guidelines For Computerized System Part- 2

Quality Assurance

Project Phase Validation4.1 The validation documentation and reports should cover the relevant steps of the life cycle. Manufacturers should be able to justify their standards, protocols, acceptance criteria, procedures and records based on their risk assessment. 4.2 Validation documentation should include change control records (if applicable) and reports on any deviations observed during the validation

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EU Guidelines For Computerized System Part -1

Quality Assurance

PrincipleThis annex applies to all forms of computerised systems used as part of a GMP regulated activities. A computerised system is a set of software and hardware components which together fulfill certain functionalities.The application should be validated; IT infrastructure should be qualified.Where a computerised system replaces a manual operation, there should be no resultant decrease

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Manufacture of Liquids, Creams and Ointments

Production

PrincipleLiquids, creams and ointments may be particularly susceptible to microbial and othercontamination during manufacture. Therefore special measures must be taken to prevent any contamination. Premises and equipment The use of closed systems for processing and transfer is recommended in order to protect the product from contamination. Production areas where the products or open clean containers

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