GMP & Guidelines
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...
GMP & Guidelines
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,...
GMP & Guidelines
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...
GMP & Guidelines
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...
GMP & Guidelines
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...
GMP & Guidelines
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...
GMP & Guidelines
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...
GMP & Guidelines
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...