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Classification of Impurities

Impurities can be classified into the following categories: Organic Impurities (Process And Drug-Related) Inorganic Impurities Residual Solvents Organic Impurities : Organic impurities can arise during the manufacturing process and/or storage of the new drug substance. They can be identified or...

Concurrent Validation

Description: Concurrent Validation is one the approach of Process Validation where batches are released for marketing prior to approval of batches of complete validation package based on data of individual batch. Concurrent Validation In concurrent validation,...

CEHT (Clean Equipment Hold Time Study)

Why is the CEHT important for the control of a cleaning process? Essentially the reason is that nothing stays clean forever. It should be realized that recontamination of the equipment may be an event-related...

Fire Extinguisher-Safety Guidelines

What is fire? Fire is the rapid oxidation of a material in the exothermic chemical process of combustion, releasing heat, light, and various reaction products. Classification of Fire : There are six classes of fire Class A Fires – combustible materials: caused by flammable solids, such as wood, paper, and fabricClass B Fires – flammable...

MACO Calculation

Maximum Allowable Carryover (MACO) shall be calculated based upon theses three criteria. Using Health Based Data Based on Therapeutic Daily Dose (TDD) Based on LD50 Acceptance Criteria using Health Based Data CalculateADE (Acceptable Daily Exposure) according to following equation & use the...

Personal Protective Equipment (PPEs)- Safety Guideline

What is PPE? PPE can include items such as safety helmets, gloves, eye protection, hazmat suits, high-visibility clothing, safety footwear, safety harnesses, ear plugs, ear defenders and respiratory protective equipment (RPE). In appropriate situations disposable PPE...

Dealing With Industrial Emergency Conditions-Safety Guidelines

This covers basic steps to handle emergencies in the workplace.These emergencies include accidental releases of toxic gases, chemical spills, fires, explosions, and bodily harm and trauma caused by workplace violence. Planning : The plan must include, as a...

USFDA New Data Integrity and Compliance Guideline

(published in Dec 2018) Background : The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (cGMP) for drugs, as required in 21 CFR parts 210, 211, and...

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