Operational Manual Dhabe Herbals

OPERATIONAL MANUAL
GOOD MANUFACTURING PRACTICES

ISO 22716:2007
DHABE HERBALS PRIVATE LIMITED

ADDRESS: SHOREA 32, JETVAN COLONY, SAI COMPOUND, NEAR GOGA BABA TEMPLE
NEAR OPEN GYM, CHH. SAMBHAJINAGAR (AURANGABAD) 431002
MO. 9923700222, Email: dhabeherbals@gmail.com
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INDEX
SR. NO. PARTICULARS PAGE NO
1 Quality Policy 3
2 Introduction to Organization 4
3 Brief Note About ISO 22716:2007 8
4 Certificates 10
5 Products List 13
6 Process flow of Product Manufacturing 15
7 Standard Operating Processes of Products 16
8 Work Instructions for Control of Documents 25
9 Improvement Plan 31
10 Work Instructions for Purchase 32
11 Work Instructions for Stock 33

12 Work Instructions for Production 34
13 Work Instructions for Quality Control 35
14 Work Instructions for Pest Control Management 36
15 Work Instructions for Sales 39
16 Work Instructions for Internal Audit 40
17 Work Instructions for HR 41

18 Work Instructions for MR 42
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DHABE HERBALS PRIVATE LIMITED DOC NO : 1
ADD: SHOREA 32, JETVAN COLONY, SAI DHA/POL/01

COMPOUND NEAR GOGABABA TEMPLE, NEAR REV NO : - 00
OPEN GYM, CHHATRAPATI SAMBHAJINAGAR
(AURANGABAD) DATE : 02.04.2024
QUALITY POLICY
We at Dhabe Herbals Private Limited take considerable pride in developing,

sustaining unsurpassed levels of quality in manufacturing of Herbal Cosmetics
products in order to meet customer satisfaction.
Our Quality Comprises of:
1) Manufacturing and supplying excellent quality of Herbal Cosmetics

products to consistently meet the needs of esteemed customers and the
mankind in general.
2) Ensuring strict compliances with ISO guidelines, prevailing national and
international standards in accordance with Herbal Cosmetics products
Manufacturing Industry.
3) Treating health, Safety and environmental protection as an Integral part of
the quality strategy.
4) Enhancing Customer satisfaction through continuous improvement of
Quality Management System in conformity with GMP ISO 22716:2007
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DHA/ORG/01
ADD: SHOREA 32, JETVAN COLONY, SAI
INTRODUCTION TO THE ORGANIZATION
Dhabe Herbals Private Limited is one of the leading manufacturing units of Herbal
Cosmetics products operated at Chh. Sambhajinagar. We are Manufacturers of Ayura
Herbal Face Pack, Ayura Herbal Black Henna, Ayura Herbal Brown Henna, Ayura Herbal
Hair Wash, Ayura Herbal Wax Powder, Ayura Herbal Utane, Ayura Herbal Handmade
Soaps, Ayura Herbal Aloe vera Gel, Ayura Natural Henna, Massage Oil, Herbal Hair oil,
Herbal Massage Oil (pain oil), Abhyang Snaan Oil, Herbal Shampoo, Kajal, Lip Balm, DTan
Face pack, Foot Crack Cream, Pigmentation Cream, Magical Face Powder, Face Cream,
Face Cleanser, Scrub, Sunscreen, Herbal Healing Oil, Clay Pack, Herbal Lipsticks, Herbal
Lotions.
Director Information
Mrs. Archana Arvind Dhabe
1. Post held : Director, Dhabe Herbals Pvt. Ltd., Aurangabad

2. Date of Birth : 30/09/1978
3. Educational Qualifications : B. Sc. (Botany, Chemistry, Microbiology)
: P G Diploma in Fermentation, Distillery and Wine
Technology
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: Ayurved Vaidya Visharad (AVV)
: ND (Diploma in Naturopathy)
4. Trainings Completed : “How to start your own Business/ Startup”
conducted by
MCED, Aurangabad
: “Process and Product Standardization” conducted by
MCED, Aurangabad
5. Activities : Manufacturing and selling Homemade Herbal
Powders Herbal Cosmetics, Herbal Nutraceuticals at small scale
6. Participated in Exhibitions : Aurangabad Municipal Corporation,
Cum sales organized by : Maha Agro, Dept of Agriculture, Govt. of
Maharashtra
: Maharashtra Khadi & Gramodyog Mandal,
Aurangabad
: Magnet Exhibition cum Sale, Aurangabad
: Diwali Festival Shoppe, Aurangabad
: Kharedi Yatra, Aurangabad
7. Address : 32, Shorea, Jetvan Colony, SAI Compound, Near
Gogababa Temple, Near Open Gym,
Chh. Sambhajinagar (Aurangabad)
8. Mobile : +91 9923700222
9. Email : archanaarvinddhabe@gmailcom
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Miss. Ayura Arvind Dhabe
Bachelor’s of Pharmacy (2020-Present)

Government College of Pharmacy, Chhatrapati Sambhajinagar (Aurangabad)
Dr. Babasaheb Ambedkar Marathwada University, Chhatrapati Sambhajinagar
(Aurangabad)
Average SGPA: 8.21
Core Modules: Pharmaceutics, Pharmacology, Organic and Medicinal Chemistry,
Formulative and Industrial Pharmacy, Pharmacognosy and Phytochemistry,
Pharmaceutical Analysis, Biopharmaceutics, and Quality Assurance
• Higher Secondary Certification (HSC) (2020)
Kendriya Vidyalaya Aurangabad

Percentage Score: 78.2 %
Core Modules: Chemistry, Physics, Biology and Math
• Secondary School Certification (SSC) (2018) Kendriya Vidyalaya Aurangabad
Percentage Score: 86%
In Plant Trainee (Sept 2023- Oct 2023) : Lupin Limited
Patent application No. 202321060874, titled "Poly Herbal Decoction for Treating Acute
Respiratory Disease Caused by Novel Corona virus," filed with the Patent Office,
Mumbai, and published in Oct 2023.
Publications:
• Pundge R. S., Dhabe A. A., Dongre S. V. ,Maraskole I. M., and Dhabe A. S.
“Phytochemical Analysis of Alysicarpus scariosus Graham”. Bioinfolet. V 20. No. 3 B.
(2023): 629 -632.
• Dhabe A. A., Shekade P. P., Chavan S. S. and Dhabe A. S. “Poly Herbal Formulation
(IB01) For the Treatment of Severe Acute Respiratory Syndrome Caused By Novel
Corona Virus SARS-CoV-2 “ Manuscript submitted for Publication.
Awards and Achievements:
• Awarded 1st prize for an article titled 'Pharmacist Strengthening Health System:
Organ Donation' in celebration of World Pharmacist Day.
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• Qualified GPAT (Graduate Pharmacy Aptitude Test) conducted by National
Testing Agency, 2023.
• Qualified GATE (Graduate Aptitude Test in Engineering - Life Sciences) conducted
by Indian Institute of Technology (IIT) Kanpur, 2023.
• Awarded 1st Prize in research paper presentation at National Conference on
Bioresources 2023, on the topic ‘Efficacy of anti-COVID-19 herbal decoction’.
• 89.91 Percentile in MHT-CET conducted by National Testing Agency (NTA), 2020.
Skills:
• Research - Investigating/researching, collecting data, and generating insights into
pharmaceutical practices
• Communication- Effective oral and written communication, able to convey ideas
clearly
• Leadership- Organizing, Coordinating, and Managing multiple responsibilities
• Public speaking- Experienced in delivering presentations and engaging audiences
through effective public speaking techniques
• Problem-Solving- Critical thinking, analyzing, and decision making
Vision statement of Dhabe Herbals Private Limited is to become India’s one of largest
manufacturer of Herbal Cosmetics products and retail, wholesale, Ecommerce
distribution platform dealing in these products which are entirely made in India using
natural herbal ingredients and having eco-friendly in nature.
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DHA/NOTE/01
BREIF NOTE ABOUT ISO 22716:2007
ISO 22716 provides a comprehensive approach for a quality management system for
those engaged in the manufacturing, packaging, testing, storage, and transportation of
cosmetic finished products. The standard has its basis in other quality management
systems, ensuring a smooth integration with those quality management systems such as
GMP, ISO 9001 or the British Retail Consortium (BRC) standard for consumer products.
The safety of cosmetic products is an issue often on the minds of manufacturers,
suppliers and regulators. Numerous regional and international standards have been
created over the years in order to enhance the quality and safety of cosmetic products,
in many instances specifically addressing requirements for manufacturers, suppliers,
wholesalers, and retailers.
ISO 22716 is a comprehensive cosmetic safety management system standard, because
it:
 Integrates the typical requirements for product and process quality Good
Manufacturing Practices requirements with other quality guidance, for example
as laid down in the prerequisites for ISO 9001.
 Allows for easy implementation in organizations of all sizes and levels of
complexity.
 Forms an internationally accepted basis for quality and safety compliance in the
cosmetic products supply chain.
 Fosters legal compliance as adopted by regulators around the world.
 Controls and reduces cosmetic products hazards and promotes continuous
improvement throughout the supply chain.
 ISO 22716 Certification enhances continuous improvements.
 Organizations with an existing quality management program can incorporate the
elements of ISO 22716 into their existing quality management system by using a
stepwise approach to achieve compliance with global cosmetic GMP principles.
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 An organization with any of the existing cosmetic quality program can build on
their existing platform and seamlessly transition to ISO 22716.
 The ISO 22716 standard combines general principles of quality management in
organizations with the typical elements of cosmetic product GMP with a risk
management based approach.
The advantage and simplicity of ISO 22716 is that it combines the benefits of GMP
linking cosmetic product safety with overall business improvement tools that enable
organizations to meet global consumer demand for cosmetic product safety
certification.
The ISO 22716 standard has been prepared for consideration by the cosmetic industry
and takes into account the specific needs of this sector. The standard focuses on the
production, control, storage and shipment of cosmetic products. These guidelines offer
organizational and practical advice on the management of the human, technical and
administrative factors affecting product quality.
Good manufacturing practices (GMP) are essential to any organization looking to reduce
the risk and liability of their cosmetics product that can result from poor handling within
their operation.
ISO 22716 introduces a management systems approach to documenting and regulating
the production, control, storage, and shipment of cosmetic products. The standard’s
guidelines will provide your organization with practical methods for managing the many
factors that can affect product quality.
Good Manufacturing Practices (GMP, also referred to as 'CGMP' or 'current Good

Manufacturing Practice') is the aspect of quality assurance that ensures that medicinal
products are consistently produced and controlled to the quality standards appropriate
to their intended use and as required by the product specification.
GMP defines quality measures for both production and quality control and defines
general measures to ensure that processes necessary for production and testing are
clearly defined, validated, reviewed, and documented, and that the personnel, premises
and materials are suitable for the production of pharmaceuticals and biologicals
including vaccines. GMP also has legal components, covering responsibilities for
distribution, contract manufacturing and testing, and responses to product defects and
complaints. Specific GMP requirements relevant to classes of products such as sterile
pharmaceuticals or biological medicinal products are provided in a series of annexes to
the general GMP requirements.
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DHA/CERT/01
CERTIFICATES
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DHA/PRD/01
PRODUCTS LIST
Herbal Hair Oil
Herbal Handmade Soap
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HERBAL FACEPACK
HERBAL SHAMPOO
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DHA/MANU/01
PROCESS FLOW OF PRODUCT MANUFACTURING
Acquire Herbal raw

material
Raw Material is
aggregated and
tested for quality
Raw Material is
given for
production
Products are
manufactured as
per process
Manufactured
product is checked
for quality
Packed Products are

Products are packed sold by retail,
by Natural & Ecommerce and
Ecofriendly material distribution channels
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DHA/PRC/01
STANDARD OPERATING PROCESSES OF PRODUCTS
Hair Oil
Acquire herbs and

flowers from farm
Double wash and

clean the herbs and
flowers
Naturally dry the

herbs and flowers in
sun light
Deep Clean Iron Pour pure Coconut

VAT oil into iron VAT
Heat Coconut oil

over medium flame
for 25 mins
Continue on next page

Switch off Heat and
add processed herbs
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and flowers
Switch on heat at
low
Stir slowly till clear

oil color changes to
herb and flower
colors
Switch on heat at
low
Stir slowly for 10

mins
Pour cool oil into a

fresh iron VAT
Cool the mix for 8 to

10 Hrs.
Strain the oil with a

clean muslin cloth
Pour the clean

strained oil into an
airtight Stainless
steel container
Measure oil and Package, Store and

pour in bottle and dispatch as per
seal it.
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Herbal Handmade Soap
Melt the Glycerine
soap
Add the minced

herbs, citrus zest,
two drops of
essential oil
Pour the Mixture

into Mold
Dry soap in proper

sunlight
Packaging of the
product
Store and dispatch

as per order
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Herbal Powder
Acquire pure
Shadow dried herbs
& flowers directly
from farmers
Quality Control-1
to remove all
impurities
manually for 2
times
Quality Control-2
perform magnet
test to check for a
metals in the stock
Store in Stainless
Steel airtight
containers
Hand grinds
herbs & flowers
tocoarse powder
Measure and mix

coarsely ground
Deep Clean
Stainless Steel herbs and flower
container in large stainless
steel VAT
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Mix the Hand grind
herbs & flowers
formula to a fine
powder
Transfer finely
ground powder
mix to stainless
steel storage
container
QC-3 perform
magnet test to
check metals in
the stock
QC-4 to remove all

immunities
manually for 2
times
Measure powder
mix & pour in Store and dispatch
customer as per order
container and seal
with airtight
wrapping.
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Massage Oil
Herbal Ingredients
Mix ingredients at
20o C
Keep the mixture

for 20 hrs
Quality Check
Pack in bottles
Store and dispatch

as per order
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Herbal Shampoo
Soak Soap nuts,
dried gooseberry
and dried shikakai
for 12 hrs
Boil the mixture

over medium heat
Scoop out the soap

nuts & remove the
seeds
Boil a pot of Aloe

vera, hibiscus &
tulsi leaves
Combine both pots

then blend mixture
Strain the liquid

into glass jar
Packaging of
products
Store and dispatch

as per order
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Henna Dye Pack
Obtain Henna
leaves
Sun drying of
Henna Leaves
Grinding of dry
Henna leaves
Grinded leaves
kept at cool place
Packaging the
product
Store and dispatch

as per order
Fair Glow Pack

Obtain Gram flour,
Multani mitti
Add Shwet
chandan, Milk
powder, Turmeric,
Saffron

Grinding all
ingredients in soft
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Sun drying of
Heena Leaves
Packaging, Store
the product
Summer Skin Solution Pack
Take ripe banana,

rolled oats, yogurt
Whisk all
ingredients to form
smooth paste
Keep the paste for

natural cooling
Packaging, Store
the product
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PER/CON/01
WORK INSTRUCTIONS FOR CONTROL OF DOCUMENTS
Distribution List:
Management Representative (MR): Mrs. Archana Arvind Dhabe
Disclaimer:
This document contains confidential information. Do not distribute this document without
prior approval from Mrs. Archana Arvind Dhabe, Director, Dhabe Herbals Private Limited.
1. PURPOSE:
a) To establish and maintain a documented system to control all documents and data that
is related to the requirement of GMP ISO 22716:2007 standards.
b) To ensure that only the most recent revision of documents is available to appropriate
personnel.
c) To control that document requiring changes are revised and received the required
approvals.
2. SCOPE:
The scope of this procedure is controlling various procedures; formats and all type record
used at Dhabe Herbals Private Limited following documents are included in this procedure,
a) Organization Charts & Job Descriptions.

b) System procedures.
c) Procedure related to specific standards.
d) Standard operating procedures.
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e) Work instructions.
f) Forms / checklists / plans.
g) Reference external manuals.
h) Legal and regulatory requirement’s etc.
3. RESPONSIBILITIES:
All level 1 & 2 documents of the Quality Management System are approved by Mrs.
Archana Arvind Dhabe, Director, Dhabe Herbals Private Limited.
The Management Representative (MR) is responsible to maintain and revise this procedure
with the approval of Mrs. Archana Arvind Dhabe, Director, Dhabe Herbals Private Limited.
The Management Representative is responsible for controlling all the documents.
4. PROCEDURE:
4.1 Document Hierarchy:
Level 1: ISO 22716:2007 Manual
Level 2: GMP ISO Procedures, Organizational Policies, Process Flow
Diagram, Organization Chart, Quality Plan and SOP’s.
Level 3: Job Descriptions, Work Instructions.
Level 4 Quality Forms/Records, Specifications, and Standards.
4.2 Document Coding:
4.2.1 The header portion of all Quality Management System procedures contains,
Company Name: Dhabe Herbals Private Limited.
Document are coded as PAR/2024-0001-ZZ

 AA is the abbreviation for Organization Name, which is PARAM
 YYY is the Abbreviation used for Procedures, which is SOP.
 BB is the Document Number.
 ZZ is the Revision Number.
All documents will be initially provided by Rev: 00 for the initial release, any
further revision will be followed by Rev. 1 for 1st revision and numerically
increases for further revisions.
We set up a limit of revision numbers and then go for a complete change of
issue. We have set the limit of 05 revisions in any documents, the first issue
having an issue no. 01, and revision 00, then till revision no 04, the same issue
no. 01 will be continued. Immediately the revision no. reaches 05, we will make
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an issue change and the current status of the document will be Issue no. 02 and
revision no. 00.
The Document Codes are as follows,
a) PR Procedure
b) FM Form
c) JD Job Description
d) WI Work Instruction
e) QPL Quality Plan
f) ORG Organization
g) PFD Process Flow Diagram
h) CL Checklist
i) SOP Standard Operating Procedure
j) CEO Chief Executive Director
k) MR Management Representative
l) ISO-TL GMP ISO 22716:2007 Team Leader.
4.3 Document Coding for Forms/Formats:
For forms and formats following document coding would be followed;
AA-BB-XX-YY-R/ZZ
Where:
 AA is the code of the organization name i.e. AN
 BB is the abbreviation of Form. FM
 XX is a code of procedure /clause code /department.
 YY is code of form number.
 R/ZZ is the revision number of the record.
4.4 Document Approval (Level 1, 2):
4.4.1 Documents should be:

a) Written in a legible and comprehensive way;
b) Approved, signed and dated by authorized persons before being used;
c) prepared, updated, withdrawn, distributed, classified;
d) referenced to ensure that obsolete documents are not used;
e) Accessible to appropriate personnel;
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f) Removed from the job area and destroyed if they are out-dated.
Documents are written by the appropriate person, involved with the activity.
4.4.2 Approvals:
a) Organizational Policies, GMP ISO 22716:2007 Manual, Quality Procedures,
Organization Chart, Process Flow Diagrams, Quality Plan and SOPs are
approved by the CEO.
b) Other than above mentioned documents, all documents are approved by the
Concerned Personnel.
c) The Management Representative reviews documents in accordance with the
requirements of GMP ISO 22716:2007 before issuance.
4.5 Issuing Documents (Level 1, 2 & 3):
4.5.1 Official controlled documents are bearing a stamp of “CONTROLLED DOCUMENT”

and cannot follow distribution to any external parties. Only among office
departments it can be distributed for reference.
4.5.2 Uncontrolled photocopies are only allowed for use by external parties, e.g.
customers, auditors, etc. these are stamped on the front page as
“UNCONTROLLED DOCUMENT” and it can be distributed further.
4.5.3 The original document, signed and dated, retained in the Main File. This file
comprises separate folders for each department, containing all the GMP ISO
22716:2007 system documents for that department.
4.5.4 All documents are recorded on a “Master List of Controlled Documents” (EB-FM-
01-01-R/00).
4.6 Amending & Revising Documents:
4.6.1 In case of any change in procedures, work instructions, forms/formats are

required; it is recorded in “Change / Disposition Form” (EB-FM-01-04-R/00).
4.6.2 Changes in the documents are necessitated under the following circumstances:
a) Changes proposed by the work centers to improve the processes.
b) Changes necessitated by the induction of the new process.
c) Revision required due to change in procedures on the basis of internal audit
and/or trend analysis.
4.6.3 The change is highlighted by (*).
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4.6.4 Reason for each revision will be written and retained.
4.7 Withdrawn / Superseded Documents:
4.7.1 All documents having with older revisions are either disposed-off or kept in a
record for fixed time duration wherever applicable.
4.7.2 Superseded copies are withdrawn by the Management Representative. These

documents are marked as superseded document and stamped ‘OBSLETE
DOCUMENT’ for identification.
4.7.3 The rejected or superseded records/documents as and when required and

appropriately disposed of through “Change/ Disposition Form”, (EB-FM-01-04-
R/00) duly approved by MR.
4.8 External Origin Document:

External document will be kept by the Management Representative. He will maintain
the record in “Master List of External Origin Documents”, (EB-FM-01-02-R/00).
4.9 Document Distribution Record:

The procedures with related formats are distributed among all concerned
departments for reference purpose and their record is entered in “Documents
Distribution List” (EB-FM-01-03-R/00)
4.10 Minor Changes:
Minor changes are classified as a typographical error, spelling mistake, incorrect or

incomplete printout, and grammatical errors. In case of such minor changes, the
revision number will not change. These changes are incorporated by the custodian of
the document by writing in the superscript form. Use of BLANCO is forbidden without
changing revision number.
4.10.1 MR will archive original documents and use only other Controlled Copy folders
with complete and each document stamped CONTROLLED DOCUMENT.
4.10.2 Original documents will be archived for five years and then disposed of it.
4.10.3 Original Documents storage will be properly secured and will be in the custody of
the MR.
4.10.4 Both Hard copy as well as electronic formats will be used to archive Documents
and their legibility will be ensured.
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4.10.5 Multiple electronic Backup systems will be used to store electronic data.
5. RELATED RECORDS:
1) Master List of Controlled Documents xx-FM-01-01-R/00

2) Master List of External Origin Documents xx-FM-01-02-R/00
3) Document Distribution List xx-FM-01-03-R/00
4) Change / Disposition Form xx-FM-01-04-R/00
5) Document Disposition Log xx-FM-01-05-R/00
Name Designation Signature
Prepared by
Reviewed by
Approved by
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PER/PLN/01
IMPROVEMENT PLAN
1. Add 1 new product in a year.

2. Look forward for advance technology.
3. To increase Sale by 5% annually.
4. To appoint Distributors in Maharashtra.
5. To Establish Company Own outlets.
6. Visit to different R & D Organizations for Product Development.
7. Look forward for advance training programs for new and advance products
manufacturing.
PREPARED BY REVIEWED BY APPROVED BY

(CEO) (ISO HEAD) (MR)
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PER/PUR/01
WORK INSTRUCTIONS FOR PURCHASE

1) Purpose - To Maintain Records of Purchase.
2) Responsibility - Purchase Head.
3) Reference - GMP ISO 22716:2007.
4) Method - As Per Standard Operating Procedure as under
Sr. No. Activity Responsibility Ref Doc/Record

1 Quotations from Concern Purchase Head Demand Letter
Manufacturers/Suppliers
2 Check the requirement as per need Purchase Head Demand Letter
3 Put up for Approval of Estimated Cost Purchase Head Demand Letter
4 Letter issue to Supplier for providing the Purchase Head Letter copy
Quotations
5 Quotation Open Before Purchase Authority Purchase Authority Quotation
6 To Prepare Comparative Statement Purchase Head Comparative Statement

7 Approval of CEO Purchase Head Comparative Statement
8 To Give Order to Approved Supplier Purchase Head Order copy
9 To Check the supplied Material as per Purchase Head Delivery Challan/relevant
Quotation Document
10 To Take Entry in Assets Register/Stock Purchase Head ASSET/STOCK REGISTER
Register

(PURCHASE HEAD) (MR/ISO Head) (ISO Auditor)
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PER/RAW/01
WORK INSTRUCTIONS FOR STOCK RAW MATERIAL/FINISHED GOODS

1) Purpose - To maintain Daily Stock Records for raw material and finished goods.
2) Responsibility - Store In charge, Production In charge, Sales In charge.
3) Reference - GMP ISO 22716:2007
4) Method - As per Standard Operating Procedure as under

1 Taking Finished Goods from Production Stores In charge Stock Register
Department
2 Updating issue of Goods against stock Stores In charge Invoice
3 Reporting to product In charge regarding Stores In charge Daily Stock Register Report
product wise less stock
4 Coordinate with Sales and production team Production in Daily Production Report
to maintain stock charge, Store Daily Sales Report, Daily
Incharge,Sales In Orders,
charge
5 Maintain product wise Optimum Stock Stores In charge Monthly Stock Statement,
Sales plan, Production Plan

(STORES INCHARGE) (MR/ISO Head) (ISO Auditor)
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PER/PDN/01
WORK INSTRUCTIONS FOR PRODUCTION

1) Purpose - To Maintain and work on Production Process.
2) Responsibility - Production Head.
4) Method - As Per Standard Operating Procedure as under

1 Check Production Schedule of Day/Month Production Head Production Schedule
2 Procure Raw Material from stores as per Production Head Quality and Hygiene Norms
Quality Norms
3 Process as per formulation of Product Production Head Standard Formula set by
Quality Control Department
4 Store the product in container or Cold Room Production Head Store In charge
5 Make it available for Packaging Production Head Packaging in charge

(PRODUCTION HEAD) (MR/ISO Head) (ISO Auditor)
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PER/QLTY/01
WORK INSTRUCTIONS FOR QUALITY CONTROL (SAMPLE BASE)
SR. NO. PARTICULARS DETAILS

Good Better Best
1 Color
2 Fragrance
Regular Improved Customer Friendly
3 Packaging

(QUALITY ASSURANCE MANAGER) (ISO Head) (ISO Auditor)
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PER/PEST/01
WORK INSTRUCTIONS FOR PEST CONTROL MANAGEMENT
Purpose:
To control all the elements needed to prevent harmful factors such as insects, rodents,
birds and pests from entering In Manufacturing premises, facilities area also at the sale
counter.
Scope:
This procedure applies for all the facilities including the production/processing/packing
area, staff locker rooms, rest rooms, toilets, the stores and receiving area etc.
Responsibility:
Housekeeping In charge is Responsible for Housekeeping and Pest Control
Management at the Organization.
Herbal Cosmetics Products manufacturing facilities are subject to strict governance and
regulations to maintain the hygiene and safety of products as well as the person. Audits
and Inspection could be impacted by pest presence in your facility, so it's critically
important that there is a zero-tolerance for pest activity.
Herbal Cosmetics Products manufacturing is subject to the same pests as many other
industries but the consequences of the smallest infestation are greater than most, even
in the toughest environments pests are determined to find shelter and food in the
premises.
 Rats & Mice - Can enter buildings and facilities utilizing gaps the width of a pencil.
Even modern facilities are susceptible to rodents.
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 Flying Insects – Pose a high risk to Domestic Consumer Chemicals facilities. The
most common flying insects include House Flies, Fruit Flies, Bluebottles, Drain
Flies and Cluster Flies.
 Crawling insects – Cockroaches cause particular problems because of their ability
to find and utilize small places.
 Birds - Are known carriers of a range of harmful pathogens and were recently
cited as a “contributing factor” in human deaths.
 Stored product insects – Such as Beetles, Weevils, Moths and Mites pose hazards
to stored products and raw materials
Procedure:
1) General:
Pests pose a major threat to the safety and suitability of products
manufacturing. Good Hygiene Practices should be employed to avoid creating
our processing environment conducive to pests.
2) Preventive Access:
Manufacturing premises are kept at good repair and condition all times to
prevent pest access and to eliminate potential breeding sites. Holes, drains
and other openings where pests are likely to gain access should be kept
sealed. Wire mesh screens for example on open windows and air curtains on
doors will reduce the problem of pest entry. Animals should, whenever
possible, be excluded from the premises.
3) Potential raw materials should be stored in pest-proof containers and away

from walls and ground. Areas both inside and outside processing should be
kept clean. Refuse and garbage will be stored in covered, pest proof
containers.
4) Filth i.e. droppings by birds, insects and rodents & other objectionable matter
are monitored and provide information about pest presence inside the
production and office area.
5) Insect & Fly Catchers have been installed at various locations within the
Production area and office area to control insects. Their locations have been
37 | P a g e
indicated on the Factory Layout Map.
6) Rodent Catchers have been installed at various locations inside the
Production area. Their locations have been indicated on the Factory Layout
Map.
7) Rodent Catchers are daily monitored to find out if anything has been caught
and disposed of properly. Daily Rodent Control Monitoring Sheet.
8) An employee in the production department is tasked with this job.
9) Rodent catchers are also monitored on a weekly basis. The number of rodents
caught and missing bait are also recorded. Rodent Catcher is cleaned and
rodents are disposed of as per instructions on Weekly Bait Stations
Monitoring and Service Sheet.
10) Cockroach and Insect killer Injections are applied in the Restrooms,
Production Hall, Kitchen, Office and First Floor on a monthly or need basis and
recorded in the Insect Control Sheet.
11) Weed growth at the back of the factory is sprayed with herbicide once a
month to prevent growth of grass and rodent poison is put to discourage
rodents Backyard Control Sheet.
12) The Water Tank is cleaned once a month from the inside, Water Tank
Cleaning Sheet.

(HOUSEKEEPING INCHARGE) (MR/ISO Head) (ISO Auditor)
38 | P a g e
PER/SALES/01
WORK INSTRUCTIONS FOR SALES

1) Purpose - To Maintain records of Sales.
2) Responsibility - Leader, Sales In charge.
4) Method - As Per Standard Operating Procedure As under

1 Sales Team meeting along with yearly Leader Sales Target Action Plan Form
sales plan for year 2022-23
2 Meeting with Distributors Leader Distributors Training for Sales
Achievement
3 Meeting with Medical Representatives Sales In charge Digital Media, Appointing new
Medical Representatives
4 Sales Promotion Sales In charge Digital Media, Meeting
Distributors, Appointing new
Distributors
5 Customers Feedback Sales In charge Customer Feedback form
6 Advertisement Material for Sales In charge Stickers, Danglers, Wall Painting

Distribution
7 Promoting Company own Outlet at Sales In charge Company Own Outlet Target (Min.
Main cities 2 in a year)
8 Collecting orders from distributors Sales In charge Solar Order Register
9 Dispatch of Goods/Products Dispatch In charge Dispatch In charge Invoice
10 Raising of Bills/ Recovery of orders Sales In charge Bill Book

(SALES IN CHARGE) (MR/ISO Head) (ISO Auditor)
39 | P a g e
PER/INTA/01
WORK INSTRUCTIONS FOR INTERNAL AUDIT

1) Purpose - For Internal Audit of the Company.
2) Responsibility - MR, Department Head.
4) Method - As Per Standard Operating Procedures as under
1 To complete the Internal Audit as per MR Internal Audit Plan

plan
2 After getting internal audit points from MR Audit points

Internal Auditor send to concern person
3 After getting compliances from concern MR Audit Points

put up before CEO/Head of Organization
4 After remark prepare the internal audit Department Head Audit Compliances
compliance statement & send to MR

(MR) (Department Head) (ISO Auditor)
40 | P a g e
PER/HR/01
WORK INSTRUCTIONS FOR HR (HUMAN RESOURSE MANAGER)

1) Purpose - To maintain Records of Human Resource.
2) Responsibility - HR Manager.
4) Method - As Per Standard Operating Procedures As under:
Sr. Activity Responsibility Ref Doc/Record

No.
1 Preparation of competency matrix HR Manager Competency
Matrix
2 Preparation of List of Employees with Details of Education, HR Manager List of employees
experience and skills whenever new employee is entered
3 Conduction of induction training for new employees for 5 HR Manager Schedule of
working days induction training
4 The Induction training plan and conduct by MR for ISO awareness HR Manager Training record
to officers and organizers
5 Generation of Training needs given by concern and preparation of HR Manager Training calendar
Training Calendar based on training needs
6 Conduction of Training with the help of internal/External Faculties HR Manager Training Report
7 The effectiveness of training given should be monitor senior HR Manager Feedback forms
employee
8 In case effectiveness is not up to the mark, the proper actions HR Manager Training record &
should be taken accordingly effectiveness
9 Yearly appraisal of each employee should be done every year at HR Manager Appraisal
the end of financial year and further action should be taken

(MR) (ISO Head) (ISO Auditor)
41 | P a g e
PER/MR/01
WORK INSTRUCTIONS FOR MANAGEMENT REPRESENTATIVE (MR)

1. Purpose - To define procedures for Management Representative (MR)
2. Responsibility - Management Representative (MR)
3. Reference - GMP ISO 22716:2007
4. Method - As per Standard Operating Procedures as under:

1 MR controls documents by updating list of records, maintaining MR Procedure for document
content documents, issuing them & also ensuring usage of latest Control
decisions
2 MR issues documents & maintain the records. MR Issue Register
3 MR maintains the records at proper location & maintains proper MR List of Records
preservations.
4 MR plans annual Management Review Meetings & audits. MR MRM plan
5 MR prepares audit plan & communicate in advance. MR Audit plan
6 Conduction of internal Audit. MR Internal audit Report
7 MR maintains Audit reports, Observation Sheets & Non MR Audit observation Sheet,
Conformity reports (NCR) audit NCR
8 MR ensures that audit NCR are closed by effective closure by MR NCR
concerned head.
9 MR ensures Management Review Meetings should be as per MR MRM Plan
plan.
10 MR maintains minutes of the meeting of MRM. MR MRM Minutes
11 MR ensures awareness of principles of quality policy. MR Quality Policy
12 MR ensures maintenance of objectives by respective heads. MR Quality Policy
13 MR ensures the communication with external agency like MR Communication Record
certification body.(various plans, execution & feedbacks).

(MR) (ISO Head) (ISO Auditor)
42 | P a g e

Operational Manual Dhabe Herbals

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Operational Manual Dhabe Herbals

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OPERATIONAL MANUAL

GOOD MANUFACTURING PRACTICES

DHABE HERBALS PRIVATE LIMITED

SR. NO. PARTICULARS PAGE NO

11 Work Instructions for Stock 33

17 Work Instructions for HR 41

ADD: SHOREA 32, JETVAN COLONY, SAI DHA/POL/01

We at Dhabe Herbals Private Limited take considerable pride in developing,

Our Quality Comprises of:

1) Manufacturing and supplying excellent quality of Herbal Cosmetics

INTRODUCTION TO THE ORGANIZATION

Mrs. Archana Arvind Dhabe

1. Post held : Director, Dhabe Herbals Pvt. Ltd., Aurangabad

Bachelor’s of Pharmacy (2020-Present)

Kendriya Vidyalaya Aurangabad

BREIF NOTE ABOUT ISO 22716:2007

Good Manufacturing Practices (GMP, also referred to as 'CGMP' or 'current Good

Herbal Hair Oil

Herbal Handmade Soap

PROCESS FLOW OF PRODUCT MANUFACTURING

Acquire Herbal raw

Packed Products are

STANDARD OPERATING PROCESSES OF PRODUCTS

Acquire herbs and

Double wash and

Naturally dry the

Deep Clean Iron Pour pure Coconut

Heat Coconut oil

Continue on next page

Stir slowly till clear

Stir slowly for 10

Pour cool oil into a

Cool the mix for 8 to

Strain the oil with a

Pour the clean

Measure oil and Package, Store and

Add the minced

Pour the Mixture

Dry soap in proper

Store and dispatch

Measure and mix

Continue on next page

QC-4 to remove all

Keep the mixture

Store and dispatch

Boil the mixture

Scoop out the soap

Boil a pot of Aloe

Combine both pots

Strain the liquid

Store and dispatch

Store and dispatch

Fair Glow Pack

Continue on next page

Summer Skin Solution Pack

Take ripe banana,

Keep the paste for

WORK INSTRUCTIONS FOR CONTROL OF DOCUMENTS

a) Organization Charts & Job Descriptions.

4.2 Document Coding:

Company Name: Dhabe Herbals Private Limited.

Document are coded as PAR/2024-0001-ZZ

The Document Codes are as follows,

4.3 Document Coding for Forms/Formats: