Good manufacturing practice

It refers to the regulations given by WHO to ensure that the products used by manufacturing industries are safe, pure & effective. These regulations require a quality approach to manufacturing, enabling the companies to eliminate the instances of contamination, errors and mix ups.

GMP is also referred to as "cGMP" where "c" stands for current which reminds the manufacturers to work according to the up-to-date rules given by WHO.

GMP is divided into four classes:
1. Class A
2. Class B
3. Class C
4. Class D

1. Class A : In this class the bacterial count is zero. Laminar air flow and biosafety cabinets are         included in this class. 
2. Class B : In this class the bacterial count is more than Class A. 
3. Class C : It is the biggest area in which sequence wise rooms are present. Here fermentation, detoxification, cleaning of equipments and incubation is done. It is further divided into two areas i.e. active & inactive area. In inactive area toxin collection is done and in active area fermentation is done.
4. Class D : In this area autoclaves are present i.e decontamination and sterilization. Pure steam is provided to sterilize the equipments. Steam is also divided into pure and plant steam. Quality of pure steam is better as it is provided to the inner part of the autoclave while plant steam is provided firstly in between the jackets of the autoclave. 

Other Important points: 

- Water used in GMP is 
1. Purified water (PW)
2. Water for injection (WFI) : It is heated at 80 degree Celsius. 

- CIP means Cleaning in Place. It means cleaning of the equipment at the place where it is present. It is done by following some steps:
                                       
 In 500L fermenter, 200 L of PW is added ==>> rinsing is done==> Sodium hydroxide + PW is added again to adjust the pH ==> cleaning + Draining is done ==> PW is provided again ==> draining is done ==> WFI is provided

- SIP means sterilization in place.

- In GMP floors are made up of epoxy material, silicon is used to fill the crevices, Lysol & Sodium hypochlorite is used for cleaning of the floor. 

- SOP (Standard Operating Procedure) is needed at every step in GMP. 

- All the available equipments and materials present inside GMP are made up of stainless steel, silicon, plastic, glass instead of wood because rusting takes place on it.

- Stainless Steel used for making of fermenters is SS316 (inside) & SS314 (outside)

- A Positive Pressure is maintained inside the GMP unit so that the outside air cannot enter inside.
                                        

Do's ✔️
1. Only authorized personnel are allowed inside the clean room ( where work is taking place )
2. Only dedicated tools are allowed inside the clean room.
3. Always make sure that your head an facial hair is covered inside the clean room.
4. Use pass through properly. 
5. Maintain good airflow management.

Don'ts ✖️
1. Do not use pass through for storage
2. People who are not fully trained should not be allowed to get inside the clean room.
3. Bare clothes and fibre clothes are not allowed inside the room
4. Do not gather inside, try to maintain silence.