CURRENT GOOD MANUFACTURING PRACTICE (cGMP)

FDA

GMPs are regulations developed by

GOOD MANUFACTURING PRACTICES (GMPs)

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

GOOD MANUFACTURING PRACTICES (GMPs)

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

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

● is 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.

REGULATORY ASPECTS OF CGMP

CROSS – CONTAMINATION

MICROBIAL

CURRENT GOOD MANUFACTURING PRACTICE

REGULATORY ASPECTS OF CGMP

Guidelines promulgated by the USFDA, Administrative Order no. 220 s. 1974 on current good manufacturing practice. This administrative order was patterned after the guidelines developed in 1963 by the USFDA with the participation of drug companies.

1. Quality control

2. Production control

GOOD MANUFACTURING PRACTICES (GMP) IS A RESPONSIBILITY OF:

To audit or to inspect periodically the procedures, equipment, and facilities employed by the various areas engaged in research development, production, control, purchasing, distribution, and sale of the product.

To detect non-compliance to cGMP and to correct them

FUNCTIONS OF THE QUALITY CONTROL IN THE GMP:

A. Contamination

B. Personnel

C. Buildings

D. Equipment

AREAS OF CONCERN

● Causes financial losses.

● Bad publicity

● Harmful publicity which can have a negative effect on sales.

● Causes adverse psychological effects on the employees.

THE FOLLOWING ARE THE DISADVANTAGES OF PRODUCT RECALLS:

OBJECTIVE OF cGMP

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

BUILDINGS

must be planned for easy cleaning, maintenance and freedom from congestion and traffic

EQUIPMENT

sed for the manufacture, processing, packaging, holding, testing or control of drugs and cosmetics should be:

COMPONENT (RAW MATERIAL)

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

COMPONENT (RAW MATERIAL)

used in the manufacture and processing of drugs (including those components that undergo chemical change or are eliminated in the process) shall be withheld from such use until they have been identified, sampled, and tested for conformance with established specifications that are appropriate and adequate, and are released by the materials approval

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

ACTIVE INGREDIENT

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

INACTIVE INGREDIENT

means any substance other than “Active Ingredient” present in the drug formulation.

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

● At least twice the quantity necessary for all the required tests of identity, purity, and strength

● Complete records related to the control, use, production, distribution, and complaint are maintained to permit reconstruction of the history of the product.

● In general, records and samples are retained for a period of 5 years.

PRESERVATION: SAMPLES AND RECORDS

At least 2 years

FOR COMPONENTS:

→_____after the distribution of the last lot of the product incorporating the components has been completed

→ One year after the expiration date

FOR COMPONENTS:

of this last lot incorporating the component

At least 2 years

FOR FINISHED PRODUCTS:

→______After lot distribution is completed

→ One year after the expiration date of the product.

at least 3 years after the manufacture is completed

FOR RECORDS:

Cosmetics:

least 2 years

1 year after the expiration date of the drug’s last batch,

A Master formula records shall be retained for a period of at ______after the distribution of the last drug batch produced using the master-formula records; or _________or whichever is the shortest.

PRODUCTION AND CONTROL PROCEDURES

shall include all responsible precautions, including the following, to assure that the drugs produced have the safety, identity, strength, quality, and purity they purport to possess:

● input lines

● output lines

● operator controls

FOR EQUIPMENT AND LINES, THE PLACEMENT OF IDENTIFICATION SHALL INCLUDE

Certifiable antibiotics and insulin

are to be withheld from distribution until the letter of certification is received.

RETURNED GOODS

Shall be identified and held, held. If the condition of the container, carton, or labeling is such as to cast doubt on the identity, strength, quality or purity of the drug, It shall be destroyed or subjected to the complete protocol of testing (to assure that the material will meet all appropriate standards and specifications) before being returned to stock for warehouse, distribution, or repacking

COMPLAINT RECORDS

It is the customer who performs the final test on the product.

COMPLAINT RECORDS

A dissatisfied consumer may write in or phone in his complaint and the company must review such complaint. A decision is made whether or not an investigation is necessary.