PHARMACEUTICAL CHEMISTRY 4


STANDARDS

1. PHARMACOPEIAL STANDARDS : official standard

2. IN-HOUSE STANDARDS: unofficial standard; generated by the manufacturer; allow flexibility and mandatory in compliance to GMP.

3. REGULATORY STANDARDS:  mandated by the regulatory agencies; Bureau of Food and Drugs, World Health Organization, International Conference of Harmonization, US Food Drug Administration; for registration purposes. Example: establishing the Bio-analysis of a generic drug product to that of the innovator drug product.


Standards must cover the following points:

 1. Formula

- List of ingredients required to produce a product.

- The amount of each of the ingredient

2. Raw Material Specification

- Desirable characteristics

- Permissible range of purity

- Available in Monographs

3. Standard Operating Procedure

- Step by step procedure on how to go about the product.

4. Finished Product Specification

- Proper performance

- Purity

- Safety

- Stability

5. Packaging Material Specification

- Run on a high speed line

- Involves a complicate assembly

- Functional

- Compatible with the product

- Protect the product and assure stability

- Ship well

6. Test Method

- should be standardized and validated


Standards for Worldwide Trading : ISO


ISO - doesn't directly measure the quality of the product; standard used for other country.


Standard - to avoid defective product -> unit/product with defects -> undesirable characteristics.


Defects

1. According to measurability

a. Variable - measurable (defect)

b. Attribute - visible (defects) / obvious

2. According to Effect

a. Critical - can be harmful

b. Major - may not be harmful but will render the product useless.

C. Minor

3. According to Nature

a. Internal - subjected to testing

b. Ocular - Defect that can be seen.

c. Performance - defect will affect the function of the product.


Quality Management System - administrative & technical procedures

Quality Assurance - total quality management   

                                    a. Quality of the product

                                    b. Quality of the personnel (work)

                                    c.  Quality of the operatives   

                                    d. Quality of the company


Quality Control - includes inspection, analysis & action.