ISO 22716 Complete Package [Downolad]November 26, 2019 2023-08-01 11:47
ISO 22716 Complete Package [Downolad]
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ISO 22716 GMP Complete package
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Price: 389 $
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Cost-Effective Implementation: Much cheaper than an on-site consultant, and requires much less time than doing it from scratch
This package comes with online consulting, document reviews, continual email support for 12 months and regular update service.
This ISO package is a complete ISO 22716 2007 (Current version) document kit that contains everything including the procedures, models, processes, forms, checklists, tools, detailed guides and instructions needed to:
• Launch your ISO 22716 – GMP project.
• Create your ISO 22716 – GMP documentation.
• Quickly obtain ISO 22716 – GMP certification.
• Benefit from 12 Month Email Support Service.
Every document, every step,everything is done in a few days!
The ISO 22716 – GMP kit is also newbie-friendly and composed in a way that even allows beginners to set up an efficient ISO 22716 2007 management system from scratch without hassles.
This package takes away all the stress and makes everything so easy that you can create in less than days what would have taken months.
ISO 22716 GMP
Template SOPs & Forms List
Context of the organization
• A. ISO 22716 Cosmetic GMP Manual
• B. Sample Job Descriptions
• C. Work Instructions Samples for Equipment
• D. Standard Operating Procedures (SOP’s) and Associated Forms
Control of Records
• SOP Control of Records
• Master List of Controlled Records
• Master List of Computers
• E-Data Backup
Personnel Hygiene & Health
• Sop Personnel Hygiene & Health
• Hygiene Monitoring Checklist
• Protocol Verification Checklist
• Personal Hygiene Checklist
• Worker Health Card
• Staff Sickness record
• SOP Pest Management
• Daily Rodent Control Monitoring Sheet
• Weekly Bait Stations Monitoring and Service Sheet
• Insect Control Sheet
• Backyard Control Sheet
• Water Tank Cleaning Sheet
Control of Purchasing
• SOP Purchasing
• Supplier Questionnaire Form
• Supplier Assessment Form
• Approved Suppliers List
• Purchase Requisition
• Purchase Order
• Supplier Monitoring Report
• SOP Production
• Job Sheet
• Job Control Sheet
• Monthly Production Schedule
• Product Ingredient Form
• SOP for Finished Product
• Acceptance Criteria
• Release Form
• Product Delivery Note
• Commercial Invoice
• Disposition Form
• SOP for Management Review Meeting
• Nomination Letter for MR
• Minutes of Meeting
• SOP for Management Review Meeting
• Nomination Letter for MR
• Minutes of Meeting
• SOP for preventing Cross contamination
• Visitor Health Verification Checklist
• Visitor Register
Quality Control Lab
• SOP for Quality Control Lab
• Material Acceptance Criteria
• Test Result Review
• OUT OF SPECIFICATION (OOS) REPORT
• OOS Log
• SOP for Subcontracting
• Contractor Questionnaire Form
• Contractor Assessment-Audit Form
• Contracting Requisition
• Contract Acceptor Capability Self-Assessment Form
Complaints & Recalls
• SOP for Complaints & Recalls
• Complaint Reporting, Investigation & Follow Up Form
• Injury Reporting Form
• Recall Management Team List
• Shipping Log
• Problem Report Form for Recall
• Recall-Withdrawal Form
• Recall-Withdrawal Status Report
• ATTACHMENT A – 21 CFR part 7 subpart C
• ATTACHMENT B- Recall Public Warning Format
• SOP for Batch Release & Batch Record Review
• Batch Release Note
• Batch Records Review & Approval Log
Control of Documents
• SOP Control of Documents
• Master List of Controlled Documents
• Master List of External Origin Documents
• Document Distribution List
• Change and Disposition Form
• Document Disposition Log
Personnel & Training
• SOP Personnel & Training
• Organizational Chart
• Training Attendance Form
• Training Evaluation Form
• Training Needs Assessment Form
• Training Program
• SOP Premises
• Sanitation Record
• Master Sanitation Schedule
• Approved Chemicals List
• Daily Checklist of Restrooms / Hand Wash Facility (Production Hall)
• Factory Layout Plan
• SOP Equipment
• List of Key Equipment
• Production Log
• Equipment cleaning schedule & Log
• Preventive Maintenance Schedule & Log
• Corrective Maintenance Log
• List of Gauges & Measuring Instruments
• Calibration Schedule & Log
• SOP Storage
• Material Discrepancy Report
• Goods receipt Note – GRN
• Store Register
• Material requisition Sheet
• Nonconformance Report – NCR
• Delivery Note
• Disposal Note
Color Additives and Chemical Ingredients
• SOP for Color Additives and • Chemical Ingredients
• List of Color Additives and • Chemical Ingredients
• Color Additives Permitted for Use in Cosmetics
• Color Additives Subject to Certification & permitted for use in Cosmetics
• Provisionally Certified Colors
• Requirements for Specific Cosmetic Products
• MSDS SHEETS
Drug Free Policy
• SOP for Analysis of Data
• SOP for Drug Free Policy
• SOP for Improvement
• CPA Request Form
• CPA Log Sheet
• Suggestion Form
• Suggestion Log
Treatment of Out of Specification Product
• SOP for Treatment of Out of Specification Product
• Reprocessing Note
• 23 SOP for Deviations
• Deviation Form
• Deviation Log
• SOP for Change Control
• Change Request Form
• Change Evaluation, Approval & Review Form
• Change Log
• SOP for Internal Audit
• Audit Checklist
• Audit Findings & Recommendations Report
• Audit Follow Up Report
• Audit Log
We have already completed about 90% of the information requested on the documents. To complete them you must fill in only the name of the company, the responsible parties, and any other information unique to your company. you will be guided through the process, commenting on the elements that are needed and those that are optional.
We worked on the ISO 22716 documentation, so as to assure all its users that they have completed everything accurately and with the utmost efficiency.
THE ISO 22716 - GMP KIT GIVES YOU
INSTANT ACCESS TO THE FOLLOWING
– 27 Reports and forms templates
Understanding ISO 22716 - GMP Certification:
Importance and Benefits in the Cosmetics Industry
The cosmetics industry is a thriving business, but it’s not without scrutiny and setbacks. Proven hazardous materials such as lead have been banned, sustainable packaging is a question, water management is a challenge, and then there’s also the issue of inaccurate marketing strategies and animal testing.
As a result, manufacturers, suppliers, and contractors must ensure that their products are consistently manufactured and controlled to the required quality levels of ISO 22716.
In this post, QSE Academy explains how cosmetic companies could face those challenges and continue to meet the requirements of their field by implementing ISO 22716 Good Manufacturing Practices and getting certified.
Introduction to ISO 22716
The ISO 22716 Good Manufacturing Practices (GMP) for cosmetics guide was designed to give guidelines for the production, control, storage, packaging, labeling, shipment, and distribution of cosmetic products.
ISO 22716 is also arranged to complement current management systems in place, like the ISO 9001. It highlights the quality of cosmetic products to customers, as well the accountability and traceability in the production and distribution phases of products.
ISO 22716 GMP covers all aspects of the supply chain of cosmetics. It focuses on the safety and quality of the product, as well as the impact of products on consumers, manufacturers, retailers, suppliers, and brand holders.
However, it doesn’t deal with safety aspects for the environment’s protection or the safety of personnel involved in the plant.
Why is ISO 22716 Certification Relevant to Your Cosmetics Company?
First, let us define the word ‘cosmetics’. According to the European Union Cosmetics Directive, a cosmetic is any substance, mixture, or preparation intended to be placed in contact with:
• external parts of the human body, such as the hair system, lips, epidermis, nails, and external genital organs
• the teeth and the mucous membranes of the oral cavity.
Note that the products are viewed exclusively or mainly to cleaning, perfuming, changing the appearance, correcting odors, protecting, or keeping the said body parts in good condition.
Thorough examinations are conducted to evaluate current manufacturing and production processes.
ISO 22716 serves as a guide on how a business can commit to the production of quality, excellent, and safe cosmetic products.
Keep in mind that your cosmetic company’s manufacturing system will be inspected and audited on the following areas in accordance with the ISO 22716 guide:
• Personnel or employees
• Material management
• Facilities, buildings, premises
• Laboratory quality controls
• Production and in-process controls
• Packaging and labeling
• Complaint and recalls
• Internal audits
Benefits of ISO 22716 Certification to Cosmetic Companies
• Simple implementation and integration with other certification standards
• Control quality, good manufacturing, hazards, and risks
ISO 22716 certification aids companies attain the principles of Good Manufacturing Practices. It also helps cosmetic companies control hazards and risks associated with their products. As a result, this ensures continuous improvement throughout the supply chain.
• Process management
ISO 22716 is involved from the beginning to the end of processes. It includes manufacturers of raw materials, producers, distributors, subcontractors, importers, and exporters.
• Supply chain management
ISO 22716 certification is recognized across the world for enabling cosmetic companies to handle safety and quality compliance in the supply chain of cosmetic products.
• Legal and Regulatory compliance
Did you know that professionals in the cosmetics sector wrote ISO 22716? This certification supports the efforts of companies to maintain current and anticipated future compliance with applicable legal, regulatory, and statutory requirements.
• Risk management
ISO 22716 certification is structured to assist cosmetic companies in determining, controlling, and handling risks throughout the audit process.
Requirements of the European Union's Cosmetics Good Manufacturing Practices
EU cosmetics GMP requirements are included in the EU Cosmetics Regulation. The regulation created requirements to make sure customers and those involved in the cosmetics sector, whether European and non-European, are safe.
The legal requirements specify that all cosmetic products circulating in the European Union must be created in accordance with the ISO 22716 Good Manufacturing Practices. It covers essential processes like manufacturing, testing, labeling, packaging, distribution, and documentation.
Cosmetic companies can prove compliance either by an ISO 22716 certification or a declaration showing that the products are produced according to ISO 22716.
ISO 22716 has arranged the following specific requirements and principles:
ISO 22716 states that staff should have suitable training to manufacture, control, and store products that comply with quality standards.
It encompasses some characteristics and parameters, including an organizational chart, number of employees, key responsibilities of the management and staff, training and workshop, personal hygiene and health of staff, visitors, and untrained personnel.
Equipment should be relevant and useful for the intended purpose. All pieces of equipment must be cleaned, sanitized, and maintained. ISO 22716 requires a cosmetics company’s equipment to be designed, installed, calibrated, and have adequate back-up systems.
Moreover, use and access to equipment should be provided to authorized personnel only.
• Raw materials and packaging
ISO 22716 obliges that purchased materials, both raw and for packaging materials, should fulfill defined acceptance criteria significant to the quality of end products. It covers physical, microbiological, and chemical aspects. Likewise, the quality of water used in production must be controlled.
Proper criteria and measures must be set up for purchasing, receipt, status, release, storage, and re-evaluation of raw materials. Cosmetic companies should also provide accessible product information.
• Premises and Locations
Premises should be designed, constructed, located, and utilized to assure the protection of the product, as well as efficient cleaning, sanitation, and maintenance. This aims to minimize the risk of a mix-up of raw materials, packaging units, and products.
ISO 22716 obliges cosmetic companies to take measures in every stage of manufacturing processes and packaging operations to manufacture an end product that fulfills the identified characteristics.
Cosmetic companies should be able to ensure the availability of relevant documents, perform start-up checks, assigned batch numbers, and re-stock raw materials. They must identify in-process operations, in-process controls, and product storage during the manufacturing and packaging stages.
Subcontracting means obtaining a product or service that adheres with the requirements of the defined contract giver. A written contract of the agreement must be set, confirmed, and controlled by the contractor and subcontractor.
• Finished products
ISO 22716 compels cosmetic companies to make sure that the end products fulfill the defined acceptance criteria before distributing the products on the market. Likewise, finished products must be controlled in compliance with the set test methods.
Companies should handle storage, shipment, recalls, and returns in a way that maintains the quality of end products.
• Quality control laboratory
The quality control laboratory should apply the principles established by ISO 22716 for personnel, equipment, premises, subcontracting, and documentation.
The quality control laboratory must execute sampling, testing, and analysis to ensure relevant and necessary controls. This provides a safeguard that materials are dispensed for use and finished products are released for distribution, only if their quality meets the established acceptance criteria.
Deviations must be determined by collecting sufficient data and taking corrective measures. Another thing for cosmetic companies to remember is to identify the treatment of product that is out of specification.
• Waste Management
ISO 22716 requires cosmetic companies to dispose of wastes in a sanitary, orderly, and timely manner.
• Conducting and Controlling Changes
Authorized personnel should approve and conduct changes that could impact the finished product’s quality on the basis of adequate data.
• Handling complaints and recalls
ISO 22716 instructs that all complaints associated with the products need to be managed, investigated, reviewed, and followed-up on. Appropriate actions should be taken if there’s a recall, and corrective action must follow.
Meanwhile, both parties should concur on the system for handling complaints in the case of contracted operations.
• Performing an internal audit
Cosmetic companies are expected to monitor the implementation and status of the ISO 22716 Good Manufacturing Practices. Corrective actions should be recommended and planned if necessary.
• Proper and complete documentation
ISO 22716 states that documentation is a crucial part of Good Manufacturing Practices. Documentation aims to define GMP activities, secure evidence of processes, and prevent confusion and loss of information.
Cosmetic companies should create their own systems to establish, design, install, and maintain documentation, which must still depend on the type of products and organizational structure.
ISO 22716 2007 Version Complete kit
– Price: 389 $
– Conforms to the 2007 version of the ISO 22716 standard, the latest version
– Documentation included:: 80 documents for the implementation of ISO 22716 2007 version
– MS Office 2007, MS Office 2010, MS Office 2013
– Language of documentation English, also available in French
– Documents are fully editable – just enter all information specific to your company.
– Acceptable for the ISO 22716 certification audit? Yes, all documents required by ISO 22716 are included,
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The Complete package for ISO 22716 2007
The complete kit
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Price : 389 $
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Price : 389 $
Price : 489 $
Price : 389 $