MoM AND NATURE

Revision No. 01 Issue No. 01

Title: Production Date of Issue: 08-05-2015

Document No: MN/ SOP-10-00 Page 1 of 11

PRODUCTION

DOCUMENT CHANGE RECORD

PAGE REV DATE DETAIL OF CHANGE

Document Approval

Prepared By Approved By
Name RISHAV RAVI RISHAV RAVI KEDIA
KEDIA
Designation PROPRITOR PROPRITOR
Signature

TABLE OF CONTENTS
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Serial
Description of Changes Page No#
No#
1 Purpose 3

2 Scope 3

3 Responsibilities 3

4 Procedure 3

Disclaimer:
This document contains confidential information. Do not distribute this document
without prior approval from MoM AND NATURE.
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1.0 PURPOSE:

The purpose of this procedure is that at each stage of manufacturing and

packaging operations, steps should be taken to ensure that the finished
product meets the defined characteristics.

2.0 SCOPE:

The scope of this procedure is to the extent of ensuring the availability proper
documents for production, start up checks, assignment of Batch numbers,
Identification of In-process operations and In-Process control of Manufacturing
and Packaging Operations.

3.0 RESPONSIBILITY

TheProduction Supervisor is responsible for all activities with respect to

production and responsible for producing the correct product according to the
specified Work Instruction and for checking that the product meets the
specifications. The propritor is responsible for overseeing the Production
activities.

4.0 PROCEDURE:

4.1 Manufacturing Operations

4.1.1 Availability of relevant documents

4.1.1.1 Product formulas have been developed and written down and Work Instructions
for manufacturing each product are with the Production Supervisor.

4.1.1.2 Production Supervisor ensures that the equipment is in suitable working

condition and equipment maintenance as well as cleaning and sanitization has
been performed according to SOP for Equipment.

4.1.1.3 Production Supervisor ensures that the information with regard to product being
developed, the raw materials used, their lot numbers are available. The
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production Supervisor prepares the Material Requisition Sheet and gives it to

the proprietor.

4.1.1.4 The proprietor provide the raw material as per the Material Requisition Sheet
and notes it in the Store Register(NO.1 REGISTER)

4.1.2 Start up checks

Before starting the production the Production Supervisor ensures that:

4.1.2.1 Documents

4.1.2.1.1 All documentation relevant to manufacturing operation is available including

Work Instruction for Manufacturing Products which includes their formulas.
Production Supervisor also ensures that Work Instructions for Operating
Equipments are available.

4.1.2.1.2 Production Supervisor and the Proprietor develop the Monthly Production
Schedule in which the planning for the whole month is done.

4.1.2.2 Raw Material availability

4.1.2.2.1 All raw material is available as per Material Requisition Sheet.

4.1.2.2.2 The Production Supervisor/Production Personnel verifies that selection,

weighing and measuring of raw material by the proprietor has been done
correctly and also writes down the yield of the finished product in the
production register (no.2 register)

4.1.2.3 Equipment

Suitable equipment is available, in working condition, and has been cleaned and
sanitized as per SOP for Equipment and is ready for use and maintained.

4.1.2.4 Clearance
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Clearance of the area has been performed to avoid mixing with material and
Packaging from previous operations.

4.1.3 Assignment of a Batch number

The Production Supervisor issues batch numbers to each batch of product. The
Batch number should be same or easily relate to the batch number on the label
for finished product.

4.1.4 Identification of in-process operations

4.1.4.1 Containers

In accordance with Work Instructions for Producing Products, Raw material

should be measured or weighed into, clean and suitable containers labeled with
proper identification or directly into the equipment used for manufacturing. All
containers used in production should be labeled with name or number of the
material inside them.

4.1.4.2 Identification of Equipment and Containers

At all times it should be possible to identify major equipment and containers of

raw material and product and their control status.
The major equipment are identified through the names and numbers Labeled on
the wall beside them.
The containers of raw material and products are identified through Labels affixed
on the containers.
The transfer lines and storage tanks (if used) are identified through a label.

4.1.4.3 Label Identification System

The labels should contain the following information

 Name or identifying code
 Batch number
 Storage conditions where such information is critical to the quality of the
product
 Control status : Quarantine/Accept/Reject
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4.1.5 In-process control

4.1.5.1 Definition of In-process controls

In Process Controls and their acceptance criteria for manufacturing each product
have been defined in the Work Instruction for Manufacturing Products.

4.1.5.2 Application of In-process controls

During the production process, In-process controls are applied as per the
instructions in the relevant Work Instruction for Manufacturing Products.

4.1.5.3 Any result outside the acceptance criteria should be reported by the production
Supervisor to the proprietor and the issue should be investigated as per SOP for
Quality Control and Assurance.

4.1.5.4 Production Supervisor ensures that appropriate measures have been taken to
prevent contamination of Product, Equipment, Personnel, Raw Material,
Packaging and Labeling material from microorganisms, filth, chemicals and other
extraneous substances by following the SOPs for Personal Hygiene, Premises,
Equipment and Storage.

4.1.5.5 Production Supervisor compares the estimated output of the finished product
with the actual output and finds out the reason for any difference and notes in
on production register(no.2 register). proprietor also takes part and reviews this
process.

4.1.5.6 Production Supervisor ensure that starting and in-process controls are being
carried out with respect to cleanliness, clearance, product integrity
(weights/measurements), product uniformity, accurate filling of mixing
containers, and adequacy of mixing, prevention of mix-ups and Batch
numbering.
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4.1.6 product storage

4.1.6.1 product should be stored in suitable containers, in defined areas, and under
appropriate conditions and entry should be made in Store Register.(no.1
register)

4.1.6.2 The maximum product storage duration should be defined.

4.1.7 Re-stocking raw materials

4.1.7.1 If raw materials remain unused after weighing and are intended and deemed
acceptable to return to stock, their containers should be closed properly,

4.1.7.2 The quantity returned should also be mentioned in the store register(register
no.1) by the Production Supervisor.

4.1.7.3 Put the UNDER USE (LOOSE QTY.) label on the container and mention the
quantity leftover on that container, transfer it to the respective approved
storage area.

4.2 Packaging and Labeling Operations

4.2.1 Availability of relevant documents

4.2.1.1 Work Instructions for Packaging are available with the Production Supervisor.

4.2.1.2 Production Supervisor ensures that the equipment is in suitable working

condition and equipment maintenance as well as cleaning and sanitization has
been performed according to SOP for Equipment.

4.2.1.3 Production Supervisor ensures that packaging and labeling operations are carried
out as per Work Instructions for Packaging and Work Instructions for Labeling .
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The production Supervisor prepares the Material Requisition Sheet and lists the
Packaging Material and Labels required, and gives it to the proprietor .

4.2.1.4 The proprietor issues the Packaging material as well as Labeling Material as per
the Material Requisition Sheet and notes it in the Store Register(no.1 register)
in the Quantity Issued column.

4.2.2 Start-up checks

Before starting the production the Production Supervisor ensures that:

4.2.2.1 Clearance

Clearance of the area has been performed to avoid mixing with material and
Packaging from previous operations.

4.2.2.2 Documents

All documentation relevant to packaging operation is available including

Work Instruction for Packaging and Work Instructions for Labeling and Work
Instructions for assigning Batch Number,which includes their formulas.

4.2.2.3 Packaging and Labeling Material availability

All Packaging and Labeling material is available as per Material Requisition

Sheetand has been issued.

4.2.2.4 Equipment

Suitable equipment is available, in working order, and has been cleaned and
sanitized as per SOP for Equipment and Equipment Cleaning Schedule & Log and
is ready for use and maintained as per Preventive Maintenance Schedule & Log.

4.2.2.5 Coding/Batch Numbers

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Production Supervisor ensures that any coding to identify Product is defined as

per Work Instructions for assigning Batch Numbers.

4.2.3 Assignment of Batch number

4.2.3.1 The Production Supervisor assigns batch numbers to Finished Product Packaging,
that are permanent, unique and meaningful, according to Work Instructions for
Assigning Batch Numbers . The Batch number should be same or easily relate to
the batch number on the label for finished product.

4.2.3.2 The Production Supervisor maintains a coding system that corresponds to those
batch numbers.

4.2.4 Packaging line identification

4.2.4.1 The Production Supervisor ensures that at all times it is possible to identify the
Packaging Equipment/Packaging Line with its name.

4.2.5 Checks of on-line control equipment

If used, on-line control equipment for Packaging and Labeling should be checked
according to a defined program. (Note: At present On-line control equipment are
not being used).

4.2.6 In-process control

4.2.6.1 Definition of In-process controls

In Process Controls and their acceptance criteria for manufacturing each product
have been defined in the Work Instructions for Packaging (EB-WI-10-02-R/00)
and Work Instructions for Labeling (EB-WI-10-03-R/00).

4.2.6.2 Application of In-process controls

During the production process, In-process controls are applied as per the
instructions in the relevant Work Instructions for Packaging and Work
Instructions for Labeling .
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4.2.6.3 Any result outside the acceptance criteria should be noted in the production
register(no.2 register)by the production Supervisor. The proprietor should also
be notified and the issue should be investigated as per SOP for Quality Control
and Assurance.

4.2.6.4 The Production Supervisor ensures that during handling of Packaging material
that are intended to come into contact with product selection errors are
prevented through issuance of correct packaging materials as per the Material
Requisition Sheet. proprietor ensure issuance of correct packaging material,
which is verified by the Production Supervisor/Production staff by counter-
signing on the Store Register(no.1 register).

4.2.6.5 The Production Supervisor, with the help of in house testing QC ensure that the
packaging material is free from microbiological and chemical contamination.

4.2.6.6 Production Supervisor ensure that checks have been carried out as per Work
Control Sheet with reference to clearance, cleanliness and batch numbers.

4.2.7 Re-stocking of packaging and Labeling materials

4.2.7.1 If Packaging and Labeling materials remain unused after operations and are
intended and deemed acceptable to return to stock, their containers should be
closed and properly identified. They should be handed over to the proprietor
and entry should be made in Store Register (no.1 reister).

4.2.7.2 The quantity returned is also mentioned in the production register(no.2

register) by the Production Supervisor.

4.2.7.3 Put the UNDER USE (LOOSE QTY.) label on the container and mention the
quantity leftover on that container, transfer it to the respective approved
storage area.

4.2.8 Identification and handling of work-in process

Filling and labeling is usually a continuous process. If that is not the case, the
production Supervisor should implement special measures for segregation and
identification by using separate area for each product packaging and labeling
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marked with name and batch number of product, so that no mix-ups or

mislabeling can occur.