ECO BEAUTY WHOLESALE & LABS
Standard:
ISO 22716:2007 CGMP
Revision No.
Title:
Production
Date of Issue:
Document No:
EB/ SOP-10-00
DOCUMENT CHANGE RECORD
DOCUMENT CHANGE RECORD
PAGE
REV
DATE
DETAIL OF CHANGE
Document Approval
Name
Designation
Signature
Issue No.
08-05-2015
Page 1 of 12
PRODUCTION
CCF#
01
Prepared By
Reviewed By
Approved By
MR
CEO
CEO
01
ECO BEAUTY WHOLESALE & LABS
Standard:
ISO 22716:2007 CGMP
Revision No.
Title:
Production
Date of Issue:
Document No:
EB/ SOP-10-00
Serial
No#
Description of Changes
01
Issue No.
08-05-2015
Page 2 of 12
Page No#
1
Purpose
3
2
Scope
3
3
Responsibilities
3
4
Procedure
3
5
Related Documents & Records
12
TABLE OF CONTENTS
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.
01
ECO BEAUTY WHOLESALE & LABS
Standard:
ISO 22716:2007 CGMP
Revision No.
Title:
Production
Date of Issue:
Document No:
EB/ SOP-10-00
1.0
01
Issue No.
08-05-2015
Page 3 of 12
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 Quality Controller is
responsible for checking that the product meets the specifications. The CEO is
responsible for overseeing the Production activities.
4.0
4.1
PROCEDURE:
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.
01
ECO BEAUTY WHOLESALE & LABS
Standard:
ISO 22716:2007 CGMP
Revision No.
Title:
Production
Date of Issue:
Document No:
EB/ SOP-10-00
01
Issue No.
08-05-2015
Page 4 of 12
4.1.1.3 Work Instructions should be affixed near each machine, so that the workers
know how to operate them.
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 Store Personnel 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 (EBWI-10-XYZ-R/00) are available near the equipment.
4.1.2.1.2 Production Supervisor and the CEO 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 store personnel has been done
correctly and counter-signs on the Store Register (EB-FM-09-03-R/00) and also
01
ECO BEAUTY WHOLESALE & LABS
Standard:
ISO 22716:2007 CGMP
Revision No.
Title:
Production
Date of Issue:
Document No:
EB/ SOP-10-00
01
Issue No.
08-05-2015
Page 5 of 12
verifies this in the Job Control Sheet (EB-FM-10-02-R/00) and also writes down
the yield of the finished product in the Job Sheet (EB-FM-10-01-R/00).
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 and maintained as per Preventive
Maintenance Schedule & Log (EB-FM-07-04-R/00).
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 (EB-WI-10-01R/00). 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 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 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 bulk products are identified through Labels
affixed on the containers.
01
ECO BEAUTY WHOLESALE & LABS
Standard:
ISO 22716:2007 CGMP
Revision No.
Title:
Production
Date of Issue:
Document No:
EB/ SOP-10-00
01
Issue No.
08-05-2015
Page 6 of 12
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
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 (EB-WI10-XYZ-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(EBWI-10-XYZ-R/00).
4.1.5.3 Any result outside the acceptance criteria should be reported by the worker to
the production Supervisor and noted in the Job Sheet (EB-FM-10-01-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,
01
ECO BEAUTY WHOLESALE & LABS
Standard:
ISO 22716:2007 CGMP
Revision No.
Title:
Production
Date of Issue:
Document No:
EB/ SOP-10-00
01
Issue No.
08-05-2015
Page 7 of 12
Packaging and Labeling material from microorganisms, filth, chemicals and other
extraneous substances by following the SOPs for Personal Hygiene, Premises,
Equipment, Pest Management and Storage.
4.1.5.5 Production Supervisor compares the estimated output of the finished product
with the actual output Job Sheet (EB-FM-10-01-R/00) and finds out the reason
for any difference. Quality Controller also takes part and reviews this process.
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.
Production Supervisor fills the Job Control Sheet (EB-FM-10-02-R/00) through
which in-process controls are monitored and the QC verifies them.
4.1.6 Bulk product storage
4.1.6.1 Bulk product should be stored in suitable containers, in defined areas, and under
appropriate conditions and entry should be made in Store Register (EB-FM-0903-R-00) and Quick Books Inventory System.
4.1.6.2 The maximum bulk product storage duration should be defined.
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 Store Personnel and entry should
be made in Store Register (EB-FM-09-03-R-00) and Quick Books Inventory
System.
4.1.7.2 The quantity returned is also mentioned in the Job Sheet (EB-FM-10-01-R/00) by
the Production Supervisor.
01
ECO BEAUTY WHOLESALE & LABS
Standard:
ISO 22716:2007 CGMP
Revision No.
Title:
Production
Date of Issue:
Document No:
EB/ SOP-10-00
01
Issue No.
08-05-2015
Page 8 of 12
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.
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, so that the workers
know how to operate them.
4.2.1.4 Production Supervisor ensures that packaging and labeling operations are
carried out as per Work Instructions for Packaging (EB-WI-10-02-R/00) and
Work Instructions for Labeling (EB-WI-10-03-R/00) and the information with
regard to packaging and labeling are available and the workers are informed. The
production Supervisor prepares the Material Requisition Sheet (EB-FM-09-04R/00) and lists the Packaging Material and Labels required, 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.
4.2.1.5 The Store Personnel issues the Packaging material as well as Labeling 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.
4.2.1.6 The Production Supervisor ensures that detailed Packaging and Labeling
information instructions are provided to the production staff with respect to
filling, closing, labeling and coding/batch numbering operations, as per Work
Instructions for Packaging (EB-WI-10-02-R/00) and Work Instructions for Labeling
(EB-WI-10-03-R/00)
4.2.2 Start-up checks
01
ECO BEAUTY WHOLESALE & LABS
Standard:
ISO 22716:2007 CGMP
Revision No.
Title:
Production
Date of Issue:
Document No:
EB/ SOP-10-00
01
Issue No.
08-05-2015
Page 9 of 12
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
Job Sheet (EB-FM-10-01-R/00) and Work Instruction for Packaging (EB-WI-1002-R/00) and Work Instructions for Labeling (EB-WI-10-03-R/00) and Work
Instructions for assigning Batch Number (EB-WI-10-01-R/00) which includes
their formulas. Production Supervisor also ensures that Work Instructions for
Operating Equipments are available near the equipment.
4.2.2.3 Packaging and Labeling Material availability
All Packaging and Labeling material is available as per Material Requisition Sheet
(EB-FM-09-04-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
(EB-FM-07-03-R/00) and is ready for use and maintained as per Preventive
Maintenance Schedule & Log (EB-FM-07-04-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 (EB-WI-10-01-R/00).
4.2.3 Assignment of Batch number
01
ECO BEAUTY WHOLESALE & LABS
Standard:
ISO 22716:2007 CGMP
Revision No.
Title:
Production
Date of Issue:
Document No:
EB/ SOP-10-00
01
Issue No.
08-05-2015
Page 10 of 12
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 (EB-WI-10-01-R/00). 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 and identifying code through
the Machine name Label affixed on the machine or the wall nearby.
4.2.4.2 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.
4.2.5 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 (EB-WI-10-02-R/00)
and Work Instructions for Labeling (EB-WI-10-03-R/00).
01
ECO BEAUTY WHOLESALE & LABS
Standard:
ISO 22716:2007 CGMP
Revision No.
Title:
Production
Date of Issue:
Document No:
EB/ SOP-10-00
01
Issue No.
08-05-2015
Page 11 of 12
4.2.6.3 Any result outside the acceptance criteria should be reported by the worker to
the production Supervisor and noted in the Job Sheet (EB-FM-10-01-R/00) as
well as Job Control Sheet (EB-FM-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.
4.2.6.4 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 (EB-FM-09-04 R/00). Store Personnel ensure issuance of
correct packaging material, which is verified by the Production
Supervisor/Production staff by counter-signing on the Store Register (EB-FM-0903-R/00).
4.2.6.5 The Purchase Officer, The Production Supervisor, Store Personnel and QC ensure
that the packaging material is free from microbiological and chemical
contamination by following the SOPs for Purchase, Storage, Premises,
Equipment, Personal Hygiene and Pest Management.
4.2.6.6 Production Supervisor and Production staff ensure that checks have been carried
out as per Work Control Sheet (EB-FM-10-02-R/00) 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 Store
Personnel and entry should be made in Store Register (EB-FM-09-03-R-00) and
Quick Books Inventory System.
4.2.7.2 The quantity returned is also mentioned in the Job Sheet (EB-FM-10-01-R/00) 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
01
ECO BEAUTY WHOLESALE & LABS
Standard:
ISO 22716:2007 CGMP
Revision No.
Title:
Production
Date of Issue:
Document No:
EB/ SOP-10-00
01
Issue No.
08-05-2015
Page 12 of 12
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 trolleys/trays for each product packaging and
labeling marked with name and batch number of product, so that no mix-ups or
mislabeling can occur.
5.0
RELATED DOCUMENTS & RECORDS:
SOP for Production
i. Job Sheet
ii. Job Control Sheet
iii. Monthly Production Schedule
iv.
Work Instructions for Assigning Batch Numbers
v.
Work Instructions for Packaging
vi.
Work Instructions for Labeling
vii. Work Instructions for Manufacturing Products
viii. Work Instructions for Operating Equipments
(EB-FM-10-01-R/00)
(EB-FM-10-02-R/00)
(EB-FM-10-03-R/00)
(EB-WI-10-01-R/00)
(EB-WI-10-02-R/00)
(EB-WI-10-03-R/00)
(EB-WI-10-XYZ-R/00)
(EB-WI-10-XYZ-R/00)
Other SOPs
i.
ii.
iii.
iv.
(EB-FM-09-04-R/00)
(EB-FM-09-03-R-00)
(EB-FM-07-03-R/00)
(EB-FM-07-04-R/00)
Material Requisition Sheet
Store Register
Equipment Cleaning Schedule & Log
Preventive Maintenance Schedule & Log
01