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

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

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.

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

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

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

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

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.