SOP for Checking the Correctness of Computerized Formulation Order Issue System

OBJECTIVE

To lay down the procedure for checking the correctness of the computerized formulation order issue system.

RESPONSIBILITY

Production Planning Supervisor / Quality Control Chemist

ACCOUNTABILITY

Production Planning Manager / Quality Assurance Manager

PROCEDURE

• Print computerized Formulation Order.
• Check the Formulation Order for

1. Manufacturing Date
2. Expiry Date
3. Master Formula
4. “First in First out” system

Manufacturing Date

• Check the formulation order for the manufacturing date.
• For example, The formulation order printed in the month of June ’2021' shall have the manufacturing date as “June 2021”.

Expiry Date

• Check the expiry date of Active Ingredient(s), against Analytical Report Number (AR. No.) Mentioned in the formulation order. Check the correctness by comparing it with the expiry date mentioned in COA. Following guidelines shall be followed while assigning Expiry for the product.
• Domestic Products: The expiry date of the Finished Product shall be as per the product's expiry date or the expiry date of its active Ingredient (s), whichever is earlier. Products having multiple active ingredient(s) shall have an expiry of Raw Material having the least expiry.
• Export Products: The expiry date of the Finished Product shall be as per the Shelf life assigned in the Master Formula.

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Master Formula

• Check the Formulation Order against the master formula issued by Product Development Laboratory for the following.

1. Code No.
2. Ingredient(s)
3. Batch Quantity
4. Actual Quantity Issued

• Calculation of active Ingredient(s) and Filler

1. Collect potency and moisture data of the active ingredients issued in the formulation order by referring to the Certificate of Analysis from Quality Control and check the same with the formulation order.
2. Calculate the actual quantity of active ingredients to be issued by referring to the formula specified in the Master Formula given by the Product Development Laboratory and the quantity of the Filler.
3. Check the correctness of the quantity by comparing it with the quantity mentioned in the Formulation order.

“First in-First out” system

• Check the “ First in – First out” System for any two ingredients issued in the Formulation order.
• In the case of active ingredients, Check for the material in stock having less expiry than that of the issued material. If there is no stock of material having less expiry, the “ First out” system shall be followed.
• After taking out the Formulation Order, check the Analytical Report Number wise stock on a computer screen. In the case of other ingredients, If there is no stock of previous Analytical Report Numbers in the system, the “First in, First out” principle shall be considered to be followed.
• In case of any discrepancy, a team comprised of

1. Production Planning Manager
2. Quality Assurance Manager
3. Manager InfoTech
4. VP (Operation)

• Shall investigate the matter and take corrective action. The investigation report shall be documented.
• Details of the investigation shall be documented as per Annexure-1.

FREQUENCY OF VALIDATION

• Five Formulation Orders of different products shall be checked during each Calendar Month.

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ABBREVIATIONS

AR No.: Analytical Reference Number

COA: Certificate of analysis

ANNEXURES

Annexure I – Investigation report.

Annexure II– General Checklist.

REVISION HISTORY  

Nil

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