ECO BEAUTY WHOLESALE & LABS

Standard: ISO 22716:2007 CGMP Revision No. 01 Issue No. 01

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

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

PRODUCTION

DOCUMENT CHANGE RECORD

DOCUMENT CHANGE RECORD

CCF# PAGE REV DATE DETAIL OF CHANGE

Document Approval

Prepared By Reviewed By Approved By

Name
Designation MR CEO CEO
Signature
 ECO BEAUTY WHOLESALE & LABS
Standard: ISO 22716:2007 CGMP Revision No. 01 Issue No. 01

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

Document No: EB/ SOP-10-00 Page 2 of 11

TABLE OF CONTENTS

Serial
Description of Changes Page No#
No#
1 Purpose 3

2 Scope 3

3 Responsibilities 3

4 Procedure 3

5 Related Documents & Records 12

Distribution List:
a) Management Representative (MR)
b) Production Department

Disclaimer:
This document contains confidential information. Do not distribute this document
without prior approval from Eco Beauty Wholesale & Labs.
 ECO BEAUTY WHOLESALE & LABS
Standard: ISO 22716:2007 CGMP Revision No. 01 Issue No. 01

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

Document No: EB/ SOP-10-00 Page 3 of 11

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

The Production Supervisor is responsible for all activities with respect to

production. The Production workers are responsible for producing the correct
product according to the specified Work Instruction. The Manager is
responsible for checking that the product meets the specifications. And
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 and each
worker.

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 Work Instructions should be affixed near each machine, so that the workers
know how to operate them.
 ECO BEAUTY WHOLESALE & LABS
Standard: ISO 22716:2007 CGMP Revision No. 01 Issue No. 01

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

Document No: EB/ SOP-10-00 Page 4 of 11

4.1.1.4 Production Supervisor ensures that the information with regard to product being
developed, the raw materials used, their lot numbers are available and the
workers are informed. The production Supervisor prepares the Material
Requisition Sheet (EB-FM-09-04-R/00) and gives it to the Store Personnel and
then prepares the Job Sheet (EB-FM-10-01-R/00) and notes all the required
information for the production run.

4.1.1.5 The Manager issues the raw material as per the Material Requisition Sheet (EB-
FM-09-04-R/00) and notes it in the Store Register (EB-FM-09-03-R-00)
in the Quantity Issued column.

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

Job Sheet (EB-FM-10-01-R/00) and Work Instruction for Manufacturing
Products (EB-WI-10-XYX-R/00) which includes their formulas. Production
Supervisor also ensures that Work Instructions for Operating Equipments (EB-
WI-10-XYZ-R/00) are available near the equipment.

4.1.2.1.2 Production Supervisor and the Manager develop the Monthly Production
Schedule (EB-FM-10-03-R/00) 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 (EB-FM-09-04
R/00) and has been issued.

4.1.2.2.2 The Production Supervisor/Production Personnel verifies that selection,

weighing and measuring of raw material by the Manager has been done
correctly and raw material are as per the Material Requisition Sheet (EB-FM-
09-04 R/00) and also writes down the yield of the finished product in the Job
Sheet (EB-FM-10-01-R/00).
 ECO BEAUTY WHOLESALE & LABS
Standard: ISO 22716:2007 CGMP Revision No. 01 Issue No. 01

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

Document No: EB/ SOP-10-00 Page 5 of 11

4.1.2.3 Equipment

Suitable equipment is available, in working condition, and has been cleaned and
sanitized as per SOP for Equipment and Equipment Cleaning Schedule & Log
(EB-FM-07-03-R/00) and is ready for use.

4.1.2.4 Clearance

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 bulk product
according to Work Instructions for Assigning Batch Numbers (MN-WI-BN-10-04-
R/00).

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 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 bulk product.
The major equipment are identified through the names and numbers Labeled on
the wall beside them.
The containers of raw material and bulk products are identified through Labels
affixed on the containers.
 ECO BEAUTY WHOLESALE & LABS
Standard: ISO 22716:2007 CGMP Revision No. 01 Issue No. 01

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

Document No: EB/ SOP-10-00 Page 6 of 11

4.1.4.3 Label Identification System

The labels should contain the Name or identifying code

4.1.4.4 Slate

Production Supervisor ensures that the Product name or identifying code and
Batch Number are visible at all times by writing them with chalk on a slate
affixed on the wall near the machine.

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 (MN-WI-
MP-10-09-R/00).

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(EB-
WI-MP-10-09-R/00).

4.1.5.3 Any result outside the acceptance criteria should be reported by the production
Supervisor to the Manager and noted in the Job Sheet (MN-JS-10-02-R/00). The
Quality Control Staff should also be notified 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 note on Job Sheet (MN-JS-10-02-R/00) and finds out
the reason for any difference. Manager also takes part and reviews this process.
 ECO BEAUTY WHOLESALE & LABS
Standard: ISO 22716:2007 CGMP Revision No. 01 Issue No. 01

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

Document No: EB/ SOP-10-00 Page 7 of 11

4.1.5.6 Production Supervisor and Production staff 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.
4.1.6 Bulk product storage

4.1.6.1 Bulk product should be stored in defined areas, and entry should be made in
Store Register (MN-SR-10-01-R-00) .

4.1.6.2 The maximum bulk product storage duration should be defined in the container
of the product.

4.1.6.3 When this duration is reached, the bulk product should be re-evaluated before
use.

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 and properly
identified, they should be handed over to the manager and entry should be
made in Store Register (MN-SR-10-01-R-00) .
4.1.7.2 The quantity returned is also mentioned in the Job Sheet (MN-JS-10-02-R/00) 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 and
also accessible to Production staff if any.
 ECO BEAUTY WHOLESALE & LABS
Standard: ISO 22716:2007 CGMP Revision No. 01 Issue No. 01

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

Document No: EB/ SOP-10-00 Page 8 of 11

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 Work Instructions should be affixed near each machine.

4.2.1.4 Production Supervisor ensures that packaging and labeling operations are carried
out as per Work Instructions for Packaging and
labeling(MN-WI-P&L-10-03-R/00) and the information with regard to packaging
and labeling are available and the workers if any are informed. The production
Supervisor prepares the Material Requisition Sheet (MN-MR-10-06-R/00) and
lists the Packaging Material and Labels required, and gives it to the manager and
then prepares the Job Sheet (MN-JS-10-02-R/00) and notes all the required
information for the production run.

4.2.1.5 The manager issues the Packaging material as well as Labeling Material as per
the Material Requisition Sheet (MN-MR-10-06-R/00) and notes it in the Store
Register (MN-SR-10-01-R/00) in the Quantity Issued column.

4.2.1.6 The Production Supervisor ensures that detailed Packaging and Labeling
information instructions are provided to the production staff if any with respect
to filling, closing, labeling and coding/batch numbering operations, as per Work
Instructions for Packaging and labeling (MN-WI-P&L-10-03-R/00)

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

 ECO BEAUTY WHOLESALE & LABS
Standard: ISO 22716:2007 CGMP Revision No. 01 Issue No. 01

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

Document No: EB/ SOP-10-00 Page 9 of 11

Job Sheet (MN-JS-10-02-R/00) and Work Instruction for Packaging and Labeling
(MN-WI-P&L-10-03-R/00) and Work Instructions for assigning Batch Number
(MN-WI-BN-10-04-R/00.

4.2.2.3 Packaging and Labeling Material availability

All Packaging and Labeling material is available as per Material Requisition Sheet
(MN-MR-10-06-R/00) and 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
(MN-WI-EC-10-06-R/00) and is ready for use and maintained as per Preventive
Maintenance Schedule & Log (MN-WI-EM-10-05-R/00).

4.2.2.5 Coding/Batch Numbers

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

per Work Instructions for Assigning Batch Numbers (MN-WI-BN-10-04-R/00).

4.2.2.6 The Production Supervisor assigns batch numbers to Finished Product Packaging,
that are permanent, unique and meaningful, according to Work Instructions for
Assigning Batch Numbers (MN-WI-BN-10-04-R/00). The Batch number should
be same or easily relate to the batch number on the label for finished product.

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

4.2.2.8 Slate
Production Supervisor ensures that the product name or identifying code and
Batch Number are visible at all times by writing them with chalk on a slate
affixed on the wall near the machine.

4.2.3 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).
 ECO BEAUTY WHOLESALE & LABS
Standard: ISO 22716:2007 CGMP Revision No. 01 Issue No. 01

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

Document No: EB/ SOP-10-00 Page 10 of 11

4.2.4 In-process control

4.2.4.1 Definition of In-process controls

In Process Controls and their acceptance criteria for manufacturing each product
have been defined in Work Instructions for Labeling and Packing (MN-WI-P&L-
10-03-R/00).

4.2.4.2 Application of In-process controls

During the production process, In-process controls are applied as per the
instructions in the relevant Work Instructions for Labeling and Packing (MN-WI-
P&L-10-03-R/00).

4.2.4.3 Any result outside the acceptance criteria should be reported by production
Supervisor to the manager and noted in the Job Sheet (MN-JS-10-02-R/00). The
Quality Control Staff should also be notified and the issue should be investigated
as per SOP for Quality Control and Assurance.

4.2.4.4 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 (EB-FM-09-04 R/00). Manager ensure issuance of correct
packaging material and note the same on the Store Register
(MN-SR-10-01-R/00).

4.2.5 Re-stocking of packaging and Labeling materials

4.2.5.1 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 manager and
entry should be made in Store Register (MN-SR-10-01/-00) .

4.2.5.2 The quantity returned is also mentioned in the Job Sheet (MN-JS-10-02-/00) by
the Production Supervisor.
 ECO BEAUTY WHOLESALE & LABS
Standard: ISO 22716:2007 CGMP Revision No. 01 Issue No. 01

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

Document No: EB/ SOP-10-00 Page 11 of 11

5.0 RELATED DOCUMENTS & RECORDS:

SOP for Production

i. Job Sheet (EB-FM-10-01-R/00)
ii. Job Control Sheet (EB-FM-10-02-R/00)
iii. Monthly Production Schedule (EB-FM-10-03-R/00)
iv. Work Instructions for Assigning Batch Numbers (EB-WI-10-01-R/00)
v. Work Instructions for Packaging (EB-WI-10-02-R/00)
vi. Work Instructions for Labeling (EB-WI-10-03-R/00)
vii. Work Instructions for Manufacturing Products (EB-WI-10-XYZ-R/00)
viii. Work Instructions for Operating Equipments (EB-WI-10-XYZ-R/00)

Other SOPs
i. Material Requisition Sheet (EB-FM-09-04-R/00)
ii. Store Register (EB-FM-09-03-R-00)
iii. Equipment Cleaning Schedule & Log (EB-FM-07-03-R/00)
iv. Preventive Maintenance Schedule & Log (EB-FM-07-04-R/00)