good manufacturing practices

Good Manufacturing Practice

Current good Manufacturing Practice Regulation are established by Food and Drug Administration. (Definition) Good Manufacturing Practices provided required minimum standards to be maintained for product manufacturing of acceptable quality and standards.

First ever GMP regulations were bring forwarded  under Kefauver Harris amendments in 1963 to ensure Good practices in the manufacturing of pharmaceuticals.  As no measures can certain that the quality of product will be according to the standards  so it is important to have a check and control on the quality of the finished product. This check and control is provided by GMP regulations.

Minimum requirements for current Good Manufacturing Practices (CGMP) or GMP are kept in 21 CFR secession 211.

This secession contain minimum requirement in equipments, process, personals and other related things to attain standards in finished pharmaceuticals.

Minimum Requirements for attaining quality standards

Under 21 CFR secession 210 and 211 these standards are written. These includes following which are discussed one by one

Minimum Standards For

a)      Organization

Organization Requirements and regulations require a proper quality control unit for

1)      Accepting or rejecting product.

2)      Attaining quality standards.

3)      Marinating product specifications.

4)      Packaging and labeling.

5)      Adequate laboratory facility

6)      Provision of written procedures

7)      Record maintenance.

a)      Personal

All personals working a in product perpetration sections or on advisory or supervisory positions must have:

1)      They must have assigned jobs and responsibilities.

2)      They must have proper skill, qualification and training.

3)      They must have periodic health checkups.

b)     Building and Facilities

1)      Proper structure, design, shape of building must be maintained. 

2)      Proper placement of equipments in building.

3)      Proper cleaning and maintenance protocols for building.

4)      Specified requirements for materials of wall, ceilings and floors.

5)      Separate area for specific tasks, like quarantine area, sterile area, storage area for raw materials and for finished products, proper area for flammable materials, specific sections for manufacturing of products like anti psychotic section or cephalosporins sections.

6)      Heat, humidity, light and environmental control.

7)      Proper ventilation of the areas.

8)      Instillation of safety and environmental control systems.

c)      Equipments

1)      Proper equipment control and selection of proper equipments for each operation.

2)      Material should have a proper quality control standards.

3)      Equipments surface must not interact with the manufacturing formulas.

4)      Proper cleaning procedures for a part or whole equipment.

5)      Periodic calibration of equipments and facilities like that required for automated equipments including computers, HPLC apparatus, PH meter etc.

6)      Filters used must be of non shedding types.

d)     Control of components, containers and closures

1)      Written record procedure for Procurement, storage, handling, sampling and testing for all of these must be maintained.

2)      Bulk pharmaceutical chemicals , chemical, containers and closures should have the same quality as described by the supplier.

3)      Lot number date and other requirement for documentation should be filled when product received or procured etc.

4)      Material procured must be quarantined before the are stored used or marketed.

5)      Rejected components must be separated so that they are easily identified.

6)      APIs are actively tested for their quality before they are used.

e)      Production and Process Control

1)      Production and Process must be controlled.

2)      Written procedures must be followed.

3)      Processed and procedures must be validated.

4)      Any deviation from validated protocol should be notified and corrected.

5)      In-process strict control must be followed.

In process control is of two types.

a)      One which is performed by production department to confirm that the process is running accordingly and smoothly just like tablet hardness test, disintegration test etc.

b)      And other which is performed by Quality control, department in order to check the standardization of the product included test may be like Assay, dissolution etc.

f)       Packaging and Labeling

Proper packaging and labeling is necessary for controlled process and production. Proper labeling of batch and product to be used or having strength, dose or quality variation should be done, so the placement of such product doesn’t make a problem.

Instructions of GMP for Packaging and Labeling are:

1)      Obsolete and outdated packaging material must be destroyed.

2)      Access to storage must be limited.

3)      Packaging and labeling material should not be used until approved by QC department.

4)      A proper labeling record must be maintained.

5)      For labeling it should be assured that previous labels are removed properly.

6)      Label should the expiration and a lot number in order to assure the proper identification of that vary product.

Expiration Date on Labels

A proper expiration date must be mentioned on the products to maintain quality, and claim standards during used of the product.

Although some product are exempted from expiration date included are homeopathic products, allergenic extracts and investigational drugs.

Temper evident packaging

Initially FDA gave regulations on tamper evident packaging in 1982 when an year earlier cyanide tempering was notices leading to dilemma.  According to FDA regulations OTC products are at top priority for temper evident packaging.  However some product may be exempted form these regulations like dentifrices, skin products, lozenges and those product which are directly supplied to institutes hospital or care providing places or homes as the tempering chance is very low in this case. 

Temper evident packaging may be Defined as  one which contain one or more indicators or barriers when product is breached or missing can easily be expected visibly. For two piece hard gelatin capsule a tow tamper evident packaging is required.

g)      Holding and Distribution

Holding and distribution must be under the record for all the raw material finished products and product to be discarded etc.  finished product must be quarantined before approval

of QC then stored. First come first out formula should be used.

Plz Comment if your Like the topic Let Me Know about your response. And Don’t forget to share. Just a one time. Thanks