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Doc No: SOP 07

Revision No: NEW


Revision Date:

Prepared By:

SECTION TITLE: STANDARD OPERATING PROCEDURES Approved By:

DOCUMENT TITLE: BATCH PROCESS CONTROL Pages: 1

PURPOSE: This SOP outlines the procedure for Batch Process Control.

PERSON MONITORING
FREQUENCY CORRECTIVE ACTIONS RECORDS
RESPONSIBLE ACTIVITY
When findings deviate from written
standards the QA designate will
document findings on the Daily / Monthly
GMP Audit Form and notify the General
Monthly GMP Manager of the deviation.
Audit Monthly GMP Audit
QA Designate As Required Daily GMP Short term action will be initiated and Daily GMP Audit.
Audit recorded on the Daily / Monthly GMP
audit form. Long term action required,
will be discussed by management and
corrective actions / responsibilities and
time frames will be agreed and
documented.

DESCRIPTION:

A series of record sheets enable batches to be followed at all major steps in the process. Between
them, they provide a detailed trail of the production process.
Individual documents and their use are described below.

Production Schedule

This document records the entire production schedule for an 8 hour period. The schedule defines
what each shift is expected to produce, listing the individual products and the quantity required.

Production Control Sheets

The Production Control Sheet is filled in by the Production lead hand, who records in sequence
the name of the product, batch number, times of major processing steps, names of operators
carrying out each step and relevant processing parameters including yields, waste and corrective
actions.

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Baking Control Sheets

The Baking Control sheet is filled in by the Oven operators, who records in sequence every
product baked, and records internal core temperatures & other processing parameters.

Packing Control Sheets

The Packing Control sheet is filled in by the Packing Supervisor, who records in sequence every
product packed, listing product name & code, the production date & the quantity packed.

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