Standard Operating Procedure for transfer of material from one code to another code in the pharmaceuticals (Code to code transfer)

1. Purpose:

To provide a standard operating procedure for transferring material from one code to another code in the pharmaceuticals (Code to Code transfer).

2. Scope

The scope of this SOP is applicable for the transfer of material from one code to another code in the pharmaceuticals (Code to Code transfer) at [company name].

3. Responsibility

User department: Demand the material required to transfer material from one Code to another Code depending on the production need and by understanding transfer suitability.

Warehouse person: The warehouse person suggests the availability of material stock, verifying the material grade, and ensuring that material manufacturer (vendor) and manufacturing location are the same for both the codes.

Warehouse head: To review the proposal

Quality Control head: To review the proposal with supporting document, compare the test results against the proposed material specification and material manufacturer’s Certificate of Analysis (CoA)

Quality Assurance head: To approve/ reject the proposal

Quality Assurance person: To transfer the material from one Code to another Code after approval of Code to Code transfer request

4. Definitions

Not applicable

5. Procedure

• On receipt of production order, the production department will check the material availability to manufacture the batch as per production order. If any material is less to fulfill the requirement of the production order, the manufacturing team will check the availability of the same material with another material code.

• This procedure is applied when the production order is received and the lead time of procurement and testing (combined) of material is more than the production delivery commitment, and the situation is unavoidable.

• Production person, with the help of warehouse person, will identify the material quantity and material code that can be transferable from one Code to another Code.

• Material stock from one Code (Code A) to another Code (Code B) can be transferred when following all the conditions are fulfilled.

i. Similar Material Name of both code materials

ii. Material stock that is to be transferred from Code A to Code B, the manufacturer name and address of Code A material should be applicable for Code B in the approved vendor list.

Example:

Material Name	Material Code	Manufacturer’s name as per approved vendor list	Manufacturer Address as per approved vendor list
Magnesium stearate	Code A	i. MS Corporation LCC ii. ABC Corporation LCC	i. Abc Street, North Pole, Alaska ii. Cda street, Ontario, Canada
Magnesium stearate	Code B	MS Corporation LCC	Abc Street, North Pole, Alaska
Magnesium stearate	Code C	MS Corporation LCC	Xyx Street, Mississippi
Magnesium stearate	Code D	ABC Corporation LCC	Cda street, Ontario, Canada

In the above example, the material, Magnesium stearate with Code A can be transferred to Code B because the manufacturer’s name and address of material Code A match with the manufacturer’s name and address applicable for material Code B. However, stock of material Code A cannot be transferred to the material Code C because the address of material Code A manufacturer is not approved for material Code C. See different permutations and combination as follows:

Stock transfer from material code	Stock transfer to material code	Allowed (Yes/ No)
Code A	Code B	Yes
Code A	Code C	No
Code A	Code D	Yes
Code B	Code A	Yes
Code B	Code C	No
Code B	Code D	No
Code C	Code A	No
Code C	Code B	No
Code C	Code D	No
Code D	Code A	Yes
Code D	Code B	No
Code D	Code C	No

iii. Manufacturing process of material Code A and Code B should be similar. A declaration from the material manufacturer should be available for the same and required to be attached with the stock transfer proposal.

iv. Certificate of Analysis of material Code A should claim material grade applicable for Code B material in addition to material Code A. Certificate of analysis of material Code A claiming both the codes should be attached with the proposal.

v. Analysis results for material Code A provided by vendor as well as in-house testing results should be compared with material Code B specification. None of the test results should be beyond the specification limit.

• User department shall request the Code to Code transfer form from QA. QA will issue the document.

• User department shall initiate the Code to Code transfer form and handover to the warehouse to provide the details about approved vendor details. Also, required details shall enter in the Code to code transfer tracking logbook.

• Warehouse department shall fill in the required details and attach the supporting documents required to process the Code to code transfer form.

• Once the details are filled and signed by the warehouse head, the form is provided to the quality control department for evaluation and specifies the requirement for additional tests to be performed.

• Quality Control head shall review the specification, method of analysis for both code materials. For any test, the method of analysis is the same for both the code materials, for those tests, additional testing is not required to be done. Remaining all tests for material Code B to be carried out by the quality control department. The quality control department head shall write the remark for the same in the Code to Code transfer form.

• When all the required criteria are met to transfer material from one Code to another Code, the form shall be reviewed and approved by Quality Assurance Head.

• After approval of the Code to Code transfer form, the QA person will transfer the material from one Code to another Code in material management system. The stock shall be transferred to “Under Test” status.

• Once the Code to Code transfer is done, required material stock shall be segregated by the warehouse person and labeled as “Under Test”.

• It is to be ensured that material transferred from one Code to another Code should be stored in the same container or simulated container where the container and closure system required to store the material should not be changed.

• Quality Control department shall sample the material to carry out the tests as suggested by Quality Control in the Code to code transfer form.

• Once the test results meet the specification, the material can be released for use.

6. Frequency

As and when required to meet the production requirement

7. Formats

7.1 Proposal for material transfer from one code to another code [Content of form]

Date:

Report Number:

Material Name:

Material A.R. No.:

Manufacturer’s batch No.:

Material code from which stock to be transferred:

Material code to which stock to be transferred:

Quantity to be transferred:

Purpose of transfer:

User department (Sign/ Date):

Details of material	Transfer from (material Code A)	Transfer to (material Code B)
Material Grade (Eg. USP, Ph. Eur. etc.)
Material Code
Material manufacturer’s name
Material manufacturer’s address
Availability of material Code A vendor name and address in approved vendor list applicable for material Code B.	—–	Yes/ No [If answer is No, material cannot be transferred from Code A to Code B]
Manufacturing process of material Code A and material Code B area same	—–	Yes/ No [If answer is No, material cannot be transferred from Code A to Code B]
Certificate of Analysis of material Code A claiming material grade applicable for material Code B	—–	Yes/ No [If answer is No, material cannot be transferred from Code A to Code B]

Attachments:

i. CoA from material manufacturer of material with material Code A [Attached/ Not attached] ii. In-house analysis CoA for material Code A [Attached/ Not attached] iii. Certificate of Analysis of material Code A claiming material grade applicable for material Code B [Attached/ Not attached] iv. Approved vendor list applicable for material Code A and Code B [Attached/ Not attached]

Warehouse department head (Sign/ Date):

Evaluation by Quality Control department head:

Quality Control department (Sign/ Date):

Evaluation by Quality Assurance department head:

Quality Assurance department head (Sign/ Date):

Materials transferred in the proposed code in material management system [Yes/ No] Quality Assurance department (Sign/ Date):

Affix the Under Test label [Yes/ No] Warehouse department (Sign/ Date):

7.2 Code to code transfer tracking logbook [Content of logbook]

Sr. No.

Date

Report Number

Material Name

Manufacture Name

Material code from which stock to be transferred:

Material code to which stock to be transferred:

Material A.R. No.:

Manufacturer’s batch No.:

Quantity to be transferred:

Purpose of transfer:

Proposed by

Checked by

Physical transfer of material done by (Warehouse person – sign/ date)

Under test label affixed by (Warehouse person – sign/ date)