3rd LESSON: Current Good Manufacturing Practice (cGMP)

Good Manufacturing Practice

ensure that products are consistently produced and controlled to the quality standards appropriate to their intended use.

Current Good Manufacturing Practice

Requiring companies to use technologies and systems that are up-to-date in order to comply with current regulations.

Administrative Order No, 220 s 1974

What is the first primary regulation for cGMP here in the Philippines?
(provides a guideline with the compliance of manufacturing a product/ checklist)

Quality System

- Is a comprehensively designed and correctly implemented system to ensure the attainment of the company’s objectives.
- It must be appropriate for its current activity.

Quality Assurance
Quality Control

What is the quality unit(s) that is independent of production and that fulfills both?

All Persons Involved

Who is responsible for quality in the manufacturing process?

Internal Audits

What should be performed regularly in accordance with an approved schedule?

Safety
Purity
Efficacy
Identity

In the Context of Pharmaceutical Aspect, how to obtain Quality?

Primary Manufacturers

focus on raw materials (API & Excipients)

Secondary Manufacturers

final dosage forms and not finished form of the product (produce your own raw materials)

Tertiary Manufacturers

packaging and labeling

Toll Manufacturers

outsource the production (A company has the facilities to produce the product from the other company)

Quality Assurance

F: Process- Oriented
G: Defect Prevention
A: Proactive

Quality Control

F: Product- Oriented
G: Identify possible defects ( Product Testing)
A: Reactive

Corrective / Preventive Action Report

An approach used to investigate and resolve quality issues along with identifying their causes. Aims to resolve compliance issues and to prevent any further recurrences.

Circular Flow

What should be designed or constructed for the flow of materials and people to prevent mix-ups or contamination in a facility?
- Facilities should also be designed to enable thorough cleaning of each building structure and facility and to minimize potential contamination from microbial agents.

In Process Product

products between production

Cemented and coated with epoxy

Floors: shall be waterproof, non absorbent, washable and non-slip material, without crevices, and shall be easy to clean and disinfect.
What should the floor be?

Curved

Walls: shall be of waterproof, non absorbent and washable, materials sealed and free of insects and shall be light colored. Up to a height appropriate for the operation, they shall be smooth and without crevices, and shall be easy to clean and disinfect.
What should be the shape of the wall?

Drinkable or Potable

In terms of water quality standards, according to WHO it should be?

HVAC- Heating, Ventilation and Air Conditioning

What type of air condition system should be used in manufacturing companies?

One year following the exp. date

For how long must production, control, and distribution records be maintained?

Traceability Purposes

Why it is important to document?

Documentation

All documents related to the manufacturer of pharmaceutical products should be prepared, reviewed, approved, and distributed.

Single line, signature, date, reason.

How should corrections be made in records?

Blue

What should be the color of the ink of the pen when signing records?

Equipment

Used in the manufacturing should be of appropriate design and adequate size, and suitably located for its intended use, cleaning, sanitization, and maintenance.

Equipment Calibration

To ensure that it is working according to its function.

Standard Operating Procedure

Details the reason behind a procedure proper sequence of steps to be done. Must be written and followed for the proper use, maintenance, and cleaning of each piece of equipment.  

Physical and Chemical Specifications

What must bulk pharmaceutical chemicals, containers, and closures meet that is established with the supplier at the time of ordering?

Certificate of Analysis

Being released for the specific materials by the supplier and basis of the manufacturer. The manufacturers should also do his/her own analysis or test the raw materials.

Green

What is the color of the container if it is “ Approved for Use”?

Red

What is the color of the container if it is “ Rejected”?

Yellow

What is the color of the container if it is “ Quarantined”?

Packaging Material

should provide adequate protection against deterioration or contamination of the pharmaceutical products that may occur during transportations and recommended storage

Laboratory Controls

Are requirement for the establishment of and conformance to written specification , standards, sampling plans, test procedures, and other such mechanisms