What is cGMP?
The abbreviation of cGMP is current Good Manufacturing
Practices. Where in current word represents to latest updation to be followed
in practice.
The cGMP
is minimum standard for methods used in and facilities or controls to be
used for the manufacturing , processing, packaging or holding of drug
substances to ensure that such drug meet the requirements of the act as to
safety, identify the strength and meets the quality.
Actually the purpose of cGMP regulations is to
give assurance for customer as they can trust on medicines which was
manufactured in that manufacturing unit or organization where cGMP is followed.
The regulatory authorities are consistently monitored the manufacturing sites
where drug products are being manufactured.
The external regulatory bodies make schedule
audit to ensure the compliance level is adequate by following the basic cGMP
requirements.
The basic cGMP requirements for Pharma operations are as followes:-
1- Organization and Personnel:-
Each Pharma operation unit should
have quality control and quality assurance with sufficient personnel. The
personnel should be trained and having rights to give approval for authorized,
reject, hold or discard the drug product based on test results. As the product
quality can be controlled.
The drug manufacturing unit should
have such type of building where sufficient space should be available to avoid
cross contamination and mix-ups. The facilities should be constructed in such a
manner as proper ventilation, sufficient light source, Air handling unit for
pure air, temperature and humidity controlled environment for drug safety
should be available. The rooms and corridors should have sufficient pressure
control as cross contamination can be avoided. A separate canteen facility,
fresh room, should be available for working personnel in respective drug
manufacturing unit. Routine health checkup to be done for personnel who
involved in drug manufacturing process.
3-Equipment and Instrument:- The drug manufacturing unit should have suitable, appropriate size and qualified Equipment and Instrument. These Equipment and Instruments should be evaluated and written procedure should be available for handling. The calibration and maintenance procedures should be available for these Equipment and Instruments.
4- Documentation system:- The validated and authentic documentation system should be available which handled all the relevant documents. The system should have controlled as only authorized personnel have rights for approval, rejection, review and preparation rights.
5- Training: - Training is important key part of drug manufacturing process. All the personnel who are performing their role in drug manufacturing, packaging, holdings, testing and release should be trained in their relevant work. Training should be documented and training record should be maintained which contains (date, time, length of training, trainer and content).
The personnel must be trained in
current Good Manufacturing practices (cGMP). It is impossible to remember
critical process on one time training for life time hence schedule training to
be performed. The frequency should be depending based on criticality of
process. All the written procedure should be available at working place as user
can follow the same by reading the process.
6- Personnel Qualification: - As per 21 CFR 211.25 each person involved in manufacturing, processing, packaging or holding of drug product shall be adequately trained, educated and experienced.
7- Effectiveness of training: - Training shall be effective as each personnel shall easily understand the content of training. The SOP shall be in easy words as experiences and fresh person both can easily understand. The assessment of training shall be done for evaluation of training. Every time self-reading is not effective training because some critical process can be missed for proper understanding. And during classroom training all the doubts goes resolved by conversation with trainer.
8- Validation: - All the area, Instrument, Equipment, process, methods should be validated. Because of based on validation it can be assured about consistency of drug product.
9- Internal Audit:- Self inspection of drug manufacturing process unit to be done on routine basis to maintain any good quality and find any gap between process. Based on updation of regulatory guidelines, updation in current procedure to be implemented.
10- Expectations of Quality: - It is expected by regulatory agencies as good quality of drug product shall be manufactured and all the standard procedures of guidelines shall be followed. Because of the consumer could not identify about purity or strength of drug product based on visual check or smell of drug product. The testing is also performed only on small amount of sample because of it is not possible to test all containers or whole amount of drug product hence consistency of drug product play an important role in human health.
Abhishek Singh is the author of Pharma technical support. He is pharmaceutical professionals, having experience of more than 12 years in Quality.