Form No.

: Comapny Name (NZ) Limited Code: Page:

RAW MATERIAL SPECIFICATION DEVELOPMENT
RMSD - FORM 1 of 4

RAW MATERIAL NAME: PRODUCT DESCRIPTION:

Instruction
This request may be completed by ANY DEPARTMENT

 It must include the reasons for the change and/or why a new raw material specification is required,
including attaching evidence where available.
 This form must be forwarded to the delegated person(s) in Technical and Regulatory Affairs (T&RA).
 T&RA is to evaluate this request and only T&RA can raise the Raw Material Specification Development
(SOP065RMSD) Form.

[Section A] Request and Justification

This specification is (circle one): New / Existing (update) / Other situation
Reason for this request: _______________________________________________________________________
___________________________________________________________________________________________

Any special requirements (For example, an assay required to quantify a component within a raw material if a
claim is being made for it, known problems with a raw material such as impurities or instability, list of countries
it should be sourced from (such as BSE free countries) or any other factors that will provide greater quality
assurance)
___________________________________________________________________________________________
___________________________________________________________________________________________

Sign______________ Date_____________ Department____________________________

T&RA Approval (please circle one)

Accepted Declined Sign______________ Date_____________

[Section B] Documentation and Raw Material Control T&RA Department ONLY

To be completed only by delegated person(s) from T&RA, the form is electronically logged into the
validated Raw Material Specification Request and Development (SOP065RMSRD) spreadsheet on the Y:/,
and a unique number to be assigned (refer to SOP065).

The RMSD Form is logged. Number__________________ Sign______________ Date___________

Are new raw materials required that are not in the Comapny Name Item Code System Yes / No
(circle)

Allocate a unique New raw material development code ____________________

(Enter on Y:/, SOP065NRMDC).

Prepared by: Checked by: Authorised by: Document:SOP065RMSD

Version: 04
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Form No.: Comapny Name (NZ) Limited Code: Page:
RAW MATERIAL SPECIFICATION DEVELOPMENT
RMSD - FORM 2 of 4

RAW MATERIAL NAME: PRODUCT DESCRIPTION:

[Section C] Product Details To be completed by T&RA

1. List products this raw material is used in or will be used in and attach copies of the product specifications.
2. Determine which products are sold in Australia, or are registered as Complementary Medicines.
3. Determine what label claim is made, and does the raw material require a valid quantitative assay.

Product TGA or Registered Complimentary Label Claim /

Product
Code Medicine or other type Assay Required

This raw material is used as Active / Excipient / Both / Other (Specify: ) (circle)
Provide function of raw material (e.g. colourant etc)

[Section D] Specification DetailsTo be completed by T&RA

Is the raw material category A or category O? ________________

Category A Raw Material

Is the raw material monographed in BP, EP or USP No Yes (circle)
Determine the most suitable monograph to be used BP EP USP (circle)
NOTE: For herbal extracts, refer to SOP 065.2 – The Determination of Identification Methods for Herbal Extracts.

Provide a justification (Please attach additional if necessary):______________________ ___________________

_____________________________________________________________________________________
_____________________________________________________________________________________

If No, is the raw material monographed in a peer reviewed pharmacopoeia or reference text? Including
but not limited to theOfficial Methods of Analysis of the Association of Analytical Chemists (AOAC), Chinese
Pharmacopoeia (CP), German Homoeopathic Pharmacopoeia (GHP), Food Chemicals Codex (FCC), Herbal Drugs
and Phytopharmaceuticals (HDP), JECFA/EUROPA (WHO | Joint FAO/WHO Expert Committee on Food Additives
(European Union)) or Japanese Pharmacopoeia (JP) or other?

If Yes, attach copy/copies of the monographs.

Determine the most suitable monograph to be used _______________________________

Provide a justification (Please attach additional if necessary):______________________ ___________________

_____________________________________________________________________________________
_____________________________________________________________________________________

If no monograph is available in any of the above documents, use the manufacturer’s specification as
set out in SOP065.1 – Raw Materials, Development of a Specification for a Raw Material (Category A) for a
Complementary Medicine Ingredient.

Category O Raw Material

Refer to SOP 065.3 - Raw Materials, Development of a Specification for a Raw Material (Category O).

[Section E] Manufacturer Details To be completed by the Purchasing Department and T&RA

Prepared by: Checked by: Authorised by: Document:SOP065RMSD

Version: 04
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Form No.: Comapny Name (NZ) Limited Code: Page:
RAW MATERIAL SPECIFICATION DEVELOPMENT
RMSD - FORM 3 of 4

RAW MATERIAL NAME: PRODUCT DESCRIPTION:

Manufacturer Supplier

Primary

Alternate

Alternate

Raw Material Details: Required for new raw materials and new manufacturers of existing raw material.
Documents To Be Collected (Compulsory) Sign / Date
1 CCRF (Attach QA approved copy) CCRF No. : .
2 Completed Supplier Approval Form
Additional Documents To Be Collected If Necessary Sign / Date
3 Information about Proprietary Ingredients (if appropriate) ARTG P.I. No.:.
4 GMO Statement □
5 Test Methods(if non-monographed) □
6 Others (e.g. country regulation, etc.)

If any documents cannot be provided, justify the reason with supporting documents.

Additional Details for Herbal Extracts:(Applies to both Category A and O raw materials, 6-8 are required for CategoryA non-monographed RM (SOP065.2)
1 Plant Name
2 Plant Part
3 Extract Ratio
4 Extraction Solvent
5 Excipient
6 Identification Method (Chromatographic)
7 Reference Extract
8 Reference Extract Documentation

Any other Oversea Market Access Requirement requirement:

Comments:

[Section F] Assessment: Draft Specification and Testing To be completed by Tech&RA

Updates
Correct category assigned No Yes (circle)

Prepared by: Checked by: Authorised by: Document:SOP065RMSD

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Form No.: Comapny Name (NZ) Limited Code: Page:
RAW MATERIAL SPECIFICATION DEVELOPMENT
RMSD - FORM 4 of 4

RAW MATERIAL NAME: PRODUCT DESCRIPTION:

Correct monograph used No Yes N/A (circle)

Checked (T&RA) Sign _____________ Date __________

T&RA approval Sign _____________ Date __________

New raw materials and new manufacturers of existing raw materials:

Correct category assigned? No Yes (circle)
Correct monograph used? No Yes N/A (circle)

Are all information / documents present? No Yes (circle)

(Section C, D & E)
Does the raw material specification (from No Yes N/A (circle)
manufacturer) comply with the required monograph?
Risk assessment completed? No Yes N/A (circle)

Raw Material complies to draft specification? No Yes (circle)

Raw Material is Acceptable Not Acceptable
Checked (T&RA/Chemistry) Sign _____________ Date __________
T&RA approval: Sign _____________ Date __________

[Section G] Documentation ControlTo be completed by Senior QA

Raw Material Specification – Document Review (T&RA)

Raw Material Approved / Rejected Sign ___________ Date __________
Specification
Comment_________________________________ __________________________

Document Issue and MASTER Copy Filed Sign ___________ Date __________
Retrieval MASTER Copy retrieved and stamped ‘Obsolete’ Sign ___________ Date _______ ___

Raw Material – Document Review (T&RA)

Approved / Rejected Sign ___________ Date ______ ____

Raw Material
Comment_________________________________ __________________________
Issue New Comapny Name Item Code : _________ Sign ___________ Date
Raw Material Code
__________
Obsolete
Development Code ______________ “Obsoleted” Sign ___________ Date ____ ______
Development Code
Raw Material
Approved / Rejected for entry into Comapny Name Supplier Approval Program
Supplier

Prepared by: Checked by: Authorised by: Document:SOP065RMSD

Version: 04
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