Standard Operating Procedure for Batch Manufacturing Record for Creams
1) Purpose
The purpose of this SOP is to define the procedures for documenting and recording all activities and information related to the manufacturing of creams to ensure consistency, traceability, and compliance with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in the manufacturing, quality assurance, and quality control of creams, including production operators, QA personnel, and supervisors. It covers the procedures for preparing, maintaining, and reviewing batch manufacturing records.
3) Responsibilities
It is the responsibility of production operators to accurately record all manufacturing activities and critical parameters during the production of creams. QA personnel are responsible for reviewing and approving batch manufacturing records to ensure compliance with approved procedures and specifications.
4) Procedure
4.1 Preparation of Batch Manufacturing Record
4.1.1 Retrieve the master batch record template or format approved for the specific cream formulation.
4.1.2 Enter the batch number, date, and other required information at the top of the batch manufacturing record.
4.1.3 Verify that the formulation details, including ingredients, quantities, and processing instructions, match the approved master formula.
4.2 Recording Manufacturing Activities
4.2.1 Document the sequential steps of the manufacturing process in the batch record, including but not limited to:
a) Weighing and dispensing of raw materials
b) Mixing and homogenization
c) Heating and cooling cycles
d) Addition of active ingredients, stabilizers, and preservatives
e) In-process testing and sampling
f) Packaging and labeling
4.3 Documentation of Critical Parameters
4.3.1 Record critical process parameters such as temperatures, mixing speeds, and batch yield at specified intervals.
4.3.2 Document deviations from the approved procedure or unexpected observations encountered during manufacturing.
4.4 Review and Approval
4.4.1 Review the completed batch manufacturing record for accuracy, completeness, and compliance with GMP (Good Manufacturing Practices) requirements.
4.4.2 Conduct a reconciliation of materials used against the approved formulation to ensure accuracy.
4.4.3 Obtain QA approval of the batch manufacturing record before further processing or packaging.
4.5 Retention and Storage
4.5.1 File the approved batch manufacturing record in a secure location or document management system for future reference and regulatory inspections.
4.5.2 Ensure batch records are retained according to regulatory requirements and company policies.
5) Abbreviations, if any
QA: Quality Assurance
GMP: Good Manufacturing Practices
SOP: Standard Operating Procedure
6) Documents, if any
Master Batch Record
Approved Formulation
In-process Testing Records
7) Reference, if any
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
US FDA CFR (Code of Federal Regulations) Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
8) SOP Version
Version 1.0