PROCEDURE FOR BATCH Doc Ref No.

: CPNL/QC-SOP-BFP-001
FORMULATION OF Issue date: 04/08/2023
PRODUCTS
Revision: 00

PROCEDURE FOR BATCH FORMULATION OF PRODUCTS

00 02/01/2020 Document Joseph Okhiku Engr. Obot Edet Chinedu Dim

Release

Rev Date Description Prepared by Supervised By Approved

 PROCEDURE FOR BATCH Doc Ref No.: CPNL/QC-SOP-BFP-001
FORMULATION OF Issue date: 04/08/2023
PRODUCTS
Revision: 00

1. Purpose:
The purpose of this procedure is to provide guidelines for the accurate and consistent
formulation of products in batch quantities. This process ensures that each batch of the
product is manufactured with the correct proportions of ingredients to maintain product
quality, safety, and performance.

2. Scope:
This procedure applies to all products manufactured by C.D. Princeton. It is applicable to the
Production department and personnel responsible for batch formulation.

3. Pre-requisites:
• Obtain the approved product formula from the Product Development department.
• Ensure that all raw materials required for the batch formulation are available, and their
quantities have been verified for accuracy.
• Prepare the necessary equipment and tools required for the formulation process,
ensuring they are clean and calibrated.

4. Batch Formulation Process:

4.1. Weighing and Measuring:
• Wear appropriate personal protective equipment (PPE), including lab coats, gloves,
and safety goggles, during the formulation process.
• Verify the cleanliness and calibration of weighing scales and measuring instruments
before starting the formulation.
• Weigh and measure each raw material according to the approved product formula.
Record the weights and measurements accurately in the batch formulation record.
• Double-check the measurements to ensure accuracy, and avoid cross-contamination
by cleaning equipment between each ingredient.

4.2. Mixing:
• Transfer the weighed and measured raw materials to the mixing vessel or equipment
as specified in the product formula.
• Start the mixing process using the appropriate mixing speed and time, as stated in the
product formula or standard operating procedure.
• Monitor the mixing process closely to ensure uniform distribution and complete
homogenization of all ingredients.
• Conduct in-process quality checks, such as pH measurement, viscosity, or specific
gravity, as required by the product specifications.
• Adjust the mixing parameters if necessary to achieve the desired product consistency
and quality.
 PROCEDURE FOR BATCH Doc Ref No.: CPNL/QC-SOP-BFP-001
FORMULATION OF Issue date: 04/08/2023
PRODUCTS
Revision: 00

4.3. Quality Control Checks:

• Collect samples from the batch for quality control testing in the designated Quality
Control laboratory.
• Analyze the samples according to the approved testing methods and compare the
results with the product specifications.
• Release the batch for further processing or packaging only after the Quality Control
department has approved the product's quality and compliance with specifications.

5. Documentation and Record Keeping:

5.1. Maintain accurate and detailed records of the batch formulation process, including the
following information:

- Batch number and date

- Raw material details (name, batch/lot number, supplier)
- Weights and measurements of each ingredient
- Mixing parameters (time, speed, temperature, etc.)
- In-process quality control checks and test results
- Signature or initials of the personnel involved in each step

5.2. Store the batch formulation records in a secure location for future reference and
traceability.

6. Approval and Release:

• Once the batch formulation is completed and all quality control checks are passed, the
batch is subject to final approval by the designated authority.
• Upon approval, the batch is released for further processing or packaging.

7. Non-Conformance Handling:
• In case of any deviations or non-conformance during the batch formulation process,
report the issue immediately to the supervisor or Quality Assurance department.
• Follow the established procedures for investigating the root cause of the non-
conformance, implementing corrective actions, and preventing recurrence.

8. Cleaning and Housekeeping:

• Clean and sanitize all equipment and work areas after each batch formulation to
prevent cross-contamination and maintain a hygienic environment.
• Dispose of any waste or unused raw materials in accordance with environmental
regulations.

9. Training and Competency:

 PROCEDURE FOR BATCH Doc Ref No.: CPNL/QC-SOP-BFP-001
FORMULATION OF Issue date: 04/08/2023
PRODUCTS
Revision: 00

• Ensure that personnel involved in the batch formulation process receive appropriate
training and are competent in following this procedure.
• Conduct periodic refresher training to update employees on any changes to the
formulation process or equipment.

10. Revision and Review:

• This procedure shall be reviewed periodically to ensure its continued suitability and
effectiveness.
• Any updates or revisions to the procedure must be approved by the appropriate
authority and communicated to all relevant personnel.

11. Approval:
This Batch Formulation Procedure has been reviewed and approved by the Technical Manager
and Chief Production Chemist on the 15th of June, 2023