cGMP A

GMPs

regulations developed by the FDA.

GMPs

are minimum requirement that the industry must meet when manufacturing, processing, packing, or holding human and veterinary drugs

cGMPs

establish personnel, facilities, and manufacturing processes to ensure that the finished drug product has the correct identity, strength, quality, and purity characteristic

Quality Control

Group within the manufacturer that is responsible for establishing process and product specifications.

Specifications

: criteria to which a drug product should conform to be considered acceptable quality for its intended us

Quality Control

tests the product and verifies that the specifications are met .

Quality Control

includes the acceptance and rejection of the incoming raw materials, packaging components, drug products, water system, and environmental conditions that exist during the manufacturing process.

Quality Assurance

the group within the manufacturer that determines that the systems and facilities are adequate, and that the written procedures are followed to ensure that the finished drug product meets the applicable specifications for quality

Good Manufacturing Practice

Ensures that products are consistently produced. The standard of quality must be suitable for use.

Administrative Order no. 220 s. 1974

AO of Regulatory Aspects of CGMP

1) Quality control 2) Production control

Good Manufacturing Practices (GMP) is a responsibility of:

1. To audit or to inspect periodically the procedures, equipment and facilities

2. To detect non compliance

Functions of the QUALITY CONTROL in the GMP:

A. Contamination

B. Personnel

C. Buildings

D. Equipment

Area of Concerns

Quality variation

Contamination (from people and environment)

Mix-ups and errors

Product recalls

a. Contamination: non-compliance to cGMP could result in the ff:

Causes financial losses.

Bad publicity

Harmful publicity which can have a negative effect on sales.

Causes adverse psychological effects on the employees

The ff. are the disadvantages of product recalls:

To produce a product that is safe, pure and effective.

Objective of cGMP

Unclean clothing

Clothes that shed lint and particles.

Objects falling out of one’s pockets

Not following SOP’

Contamination: People

Airborne particles within storage area and thru ventilation system.

Packaging machines not cleared out prior to a new packaging run

Improper dispensing of components

Inaccuracies and mix-ups in record-keeping

II. Cross Contamination: Sources

People

SOP’s not being followed.

Environment

III. Microbial: Sources

Proper education

Proper training and experience to execute technological assignments

Personnel having direct contact with drugs and cosmetics should:

Periodic health check-ups

Free from communicable diseases and open lesions on the exposed surface of the body.

Have an awareness of the importance of good personal hygiene.

Wear clean outer garments

Maintain a high degree of personal cleanliness

Should conform to hygienic practices.

B. Personnel:

1. Buildings must be planned for easy cleaning, maintenance and freedom from congestion and traffic. Buildings should provide for the ff.:

2. Adequate space for proper operation of manufacturing, processing, packaging, control and storage of products and their components

3. Adequate lighting and ventilation.

4. Adequate locker facilities, hot and cold washing facilities

5. Adequate supply of potable water under continuous positive pressure, plumbing system free from defects or contamination.

6. Suitable housing and space for the care of all laboratory animals.

7. Safe and sanitary disposal of sewage, trash, and other refuse within and from the buildings and immediate premises

Buildings:

1. Maintained in a clean and orderly manner.

2. Of suitable design, size, construction and location in relation to surroundings to facilitate maintenance and operation for its intended uses

3. Its surface should not be reactive, additive or absorptive

4. It should facilitate adjustment, disassemble, cleaning and maintenance as necessary

5. It should be of suitable type, size and accuracy intended for testing, measuring, mixing, weighing or other processing or storage operations

Equipments

Component

means any ingredient intended for use in the manufacturing of drugs, including those that may not appear in the finished product.

Batch

means a specific homogenous quantity of a drug or in case of drug produced according to single manufacturing order during the same cycle of manufacture

Lot

means a batch or any portion of a batch of a drug, produced by a continuous process

Lot number or Control Number

means any distinctive combination of letters and/or numbers, or both, by which the complete history of the manufacture, control, packaging and distribution of a batch or lot of a drug is determined

Active Ingredient

means any substance of a drug, which is intended to furnish pharmacological activity

Inactive Ingredient

Materials Approval Unit

means any organizational element having the authority and responsibility to approve or reject raw materials, in-process materials, packaging components and final products.

Strength

means (a) the concentration of a known active drug substance in the formulation (b) potency, that is, the specific ability or capacity of the product as indicated by appropriate lab.