Governing Bodies for Quality Approval

1. FDA

- Product CGMP

Governing Bodies for Quality Approval

2. Halal

-Product okay for Muslim population

(no meat in the ingredients)

Governing Bodies for Quality Approval

3. ISO (system)

International standard organization

ISO 9000 -

9001 -

9002 -

9003 -

9004 -

Governing Bodies for Quality Approval

4. HACCP

Hazard analysis and critical control point

PITFALLS in the QUEST for QUALITY

1. Instant results

- No quick fix to the quality problem

- It needs to work and think

PITFALLS in the QUEST for QUALITY

2. Lack of commitment by Management

-Effort by everyone in the company.

-Management will lead the way.

PITFALLS in the QUEST for QUALITY

3. Lack of long term planning

4. Limited application

5. Overdependence on computerized QC

PITFALLS in the QUEST for QUALITY

6. No market research

- Quality that is expected by the market.

PITFALLS in the QUEST for QUALITY

7. Lack of funds for quality process

-On the training

-Hiring qualified personnel

-Long term plan

PITFALLS in the QUEST for QUALITY

8. Underestimating the workforce

-open communication

-Everyone’s input is important, wanted and expected

-Utilize the skills and knowledge involved in the process

PITFALLS in the QUEST for QUALITY

9. Failure to acquire statistician/ consultants

-Hire consultant to train the workforce.

PITFALLS in the QUEST for QUALITY

10. Failure to involve suppliers

- Quality of incoming goods must be equal to quality of the product.

6/24/15

1. Sampling PLAN2. Manufacturing, Packaging,

Distribution control3. Statistical Quality Control

Sampling Plan

• Detailed outline of which measurement will be taken at what times

• Resulting data will contain a representative sample of the parameters of interest and allow for all questions as stated in the goals to be answered.

SAMPLE

• Taking a portion of a population for testing and analysis. The result therefore will represent the batch population.

Steps involved in developing a sample plan

1. Identify the parameters to be measured

Example

- Range of possible values

- Required solution

- Weight of the drug product

Steps involved in developing a sample plan

2. Design a sampling scheme that details how and when samples will be taken.

Steps involved in developing a sample plan

3. Select a sample size

Ex.

50s

100s

200s or more

Steps involved in developing a sample plan

4.Design data storage formats

Steps involved in developing a sample plan

5. Assign roles and responsibilities

Materials Control

-System for checking that a company has enough materials in stock for its production needs but is not storing more than it needs.

Storage limit

• 6 months - vitamins and flavors

• 12 months - active ingredients and dyes

• 24 months - active ingredients and excipients

Materials Control

1. Raw materials

2. Stickers

3. Printed and packaging materials

4. Labelling control

5. Containers

6. Reassay

Material control

1. Manufacturing monograph

2. Quality control monograph

3. Batch records

4. Standard operating procedures

-Master formula record

-batch reproduction record

-actual tests

• SOLID PREPARATION

1. Assay for active ingredients

2. Assay for degradation products

3. Disintegration

4. Dissolution/ bioavailability

5. Content uniformity

6. Weight variation

Material control

Material control

7. Identification test for active ingredients and possible contaminants

8. Visual appearance

9.Odor

10.Taste

11. Texture

12. Hardness

Material control

13.Friability

14. Powder finenes

15. Moisture content

16. Humidity effect

17. Color stability

18. Storage condition

Material control

19. Microbiological burden

20. Thickness

Packaging control

• Products

• Containers

• Strips and pouches

• Closures

• Labels

• Package insert

Packaging control

• Printing - control code/ expiration date

• Accessories

• Product unit