Assessment of Batch Numbering System and Activity

labeling System of Products using

ASEAN No.1
harmonization guidelines
& Familiarization of Tiers of Documentation
in
Manufacturing of Pharmaceutical Products

Brief Description
of the Activity
Objectives ● Evaluate the different components or labeling
requirements based on the current ASEAN GMP
guidelines
● Describe the different documents necessary in
manufacturing of pharmaceutical products
Materials

Procedure
1. Collect 2 Pharmaceutical products each category and evaluate if they complied
with the ASEAN Guidelines for labeling.
a. Tablets
b. Capsules
c. Liquid prep (syrup, suspension, etc.)
d. Herbal supplement
e. Ointment
f. Cream
2. Get from credible resources description of the following terms:
a. Quality Manual
b. Quality Procedures
c. Supporting Documents
d. Quality Records
e. Master Formula
f. Batch processing Record
g. Batch Packaging Records
h. Standard Operation Procedures
i. Working Instructions
j. Machine and Material Specification
Questions:
1. What countries belong to the ASEAN harmonization council?
2. Discuss the dynamics of ASEAN harmonization in relation to pharmaceutical
production?
3. What is the relevance of Batching System?
4. Give the difference between Batch documents and Master Formula.
5. Differentiate SOP from WI (Work Instruction)
 Worksheet

No.2

Title of the Activity Score

Course&
Student’s Name
Year/ Sec
Date
SME’s Name
Performed
Class Schedule Group No.

RESULTS AND DISCUSSIONS:

1. ASSESSMENT OF PRODUCT LABELS

PRODUCT LABEL ASSESMENT REMARKS

Tablet 1

Paste the Product Label here

Tablet 1

Paste the product Label here

Capsule 1

[paste the product label Here

Capsule 2

Paste the product Label here

Liquid prep 1

Paste the product Label here

Liquid prep 2

Paste the product Label here

Herbal supplement 1

Paste the product Label here

Herbal supplement 2

Paste the product Label here

Ointment 1

Paste the product Label here

Ointment 2

Paste the product Label here

Cream 1

Paste the product Label here

 Cream 2

Paste the product Label here

2. Manufacturing document

TERMS: DESCRIPTION
a. Quality Manual

b. Quality
Procedures

c. Supporting
Documents
d. Quality Records

e. Master Formula

f. Batch
processing
Record
 g. Batch Packaging
records
h. Standard
Operation
procedures

i. Working
Instructions

j. Machine
and Material
Specification

CONCLUSION:

ANSWERS TO QUESTION:
1. What countries belong to the ASEAN harmonization council?

2. Discuss the dynamics of ASEAN harmonization in relation to pharmaceutical

production.

3. What is the relevance of Batching System?

4. Give the difference between Batch documents and Master Formula.

5. Differentiate SOP from WI (Work Instruction)