1. 1.5 RAW MATERIAL STORAGE, QUARANTINE AND RELEASING, SOP
HHM 5014
NUTRACEUTICAL FORMULATION TECHNOLOGY
1.5 RAW MATERIAL STORAGE, QUARANTINE AND RELEASING, SOP
GROUP MEMBER:
Afiq
Nina
Syahmi

2. Storage Definition: a place or a space available to keeping items, usually in a warehouse.
Objective: maintaining quality of raw materials; such as protection from contamination.
Requirement:
Fresh products = 1 – 5°C
well-organized and tidy, good maintenance and cleanliness
Different herbal material stored in separate areas

3. Avoid Direct exposure to light, air or microbial organism effect on active component of herb which leads to lower the therapeutic efficacy of drug
Rodent and pest free
raw material should kept with proper storage with appropriate packaging material. For example, raw material that come with large quantity and heavy are suitable to keep in big wooden box compare to plastics because plastic has lower strength to hold the raw materials.

4. SOP receiving raw material
Visual examination for all incoming materials.
Intact container, lid, seals
Evidence of any physical damage to the containers
Evidence of rodent or insect specification
Proper labelling in specified manner

5. Example of packaging material for raw material storage:
Stem, bark - Gunny bags and woven sacks
Fruits and rhizomes - Wooden boxes.

6. Flower, anthers, stigma, petals, seed - Corrugated box with polypropylene woven sacks, HDPE containers
Document needed for storage:
Date raw materials received
Supplier information, ex: name
Batch number
Raw materials name

7. Quarantine material
All raw materials, components, packaging and labelling material are held “quarantine” area until they are sampled, tested or examined and released for use by “quality control laboratory”.
The procedures are designed to prevent contamination of raw materials, components and packaging materials.
It have own test procedure and specification in writing and on file
QC receive material and follow up by test procedures
Result documented and matched again with specification

8. Releasing material
Each container of each lot number of raw materials, components, packaging, and labelling materials receives a green “release” sticker.
Only containers have “release” sticker are allowed out of quarantine into the main warehouse.