GMP Certification

GMP practices are recommended to safeguard the health of consumers and patients as well as producing good quality products. Every developed & developing country has its own GMP guideline but more or less all GMP guidelines are similar & there are different enforcement agencies to ensure proper implementation of GMP guidelines. GMP compliance is necessary for you to meet requirements of these agencies (if you are exporting your products globally). GMP certification audit by CDG will make you capable to meet requirements of GMP guidelines of different nations. Our GMP certificate is recognised in different countries worldwide. Contact us today for all your GMP needs.

GMP – Good Manufacturing Practices is a set of guidelines which defines ways to manufacture certain products (Food, Pharmaceuticals, Cosmetics, Ayurvedic Products, Medical Devices & Packaging Material) under control conditions. These GMP conditions are related to product safety, hygiene, cleanliness, sanitation, clean room concept & concerned trainings. GMP includes requirements for building infrastructure, equipment’s & other resources including human resource.

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RoHS Certification

RoHS is the acronym used to refer to the European Union (EU) Directive 2002/95/EC on the Restriction of the use of certain hazardous substances in electrical and electronic equipment.

The RoHS directive currently lists 6 materials as being restricted.

Material

Maximum Concentration

Lead (Pb)

 

 

0.1% by weight

 

Mercury (Hg)

0.1% by weight

 

Cadmium (Cd)

  0.01% by weight

 

Hexavalent Chromium (Cr-VI)

0.1% by weight

 

Polybrominated Biphenyls (PBB)

0.1% by weight

 

Polybrominated Diphenyl Ethers (PBDE)

0.1% by weight

 

Above mentioned chemicals should either be totaly eliminated or should be below maximum concentration level.

Categories of electrical and electronic equipment covered by this Directive
 Large Household Appliances - Small Household Appliances - IT and Telecommunications Equipment - Consumer Equipment - Lighting Equipment - Electrical and Electronic Tools (with the exception of large-scale stationary industrial tools) - Toys, Leisure and Sports Equipment - Medical Devices (with the exception of all implanted and infected products) - Monitoring and Control Instruments - Automatic Dispensers.

CDG is a leading RoHS certification company & our RoHS certificate is recognised worldwide. Our RoHS compliance certificate is trusted by different government authorities worldwide.

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C-TPAT Certification

The Customs-Trade Partnership Against Terrorism (C-TPAT) is a supply chain security program led by U.S. Customs and Border Protection focused on improving the security of private companies' supply chains with respect to terrorism. This initiative was launched to assist the trading community in the war against Terrorism based on the below criteria:

* Business Partner Requirements (Security Procedures) * Container Security (Seals, Container Inspection etc) * Physical Access Control - Procedural Security * Security Training and Awareness * Physical Security - Information Technology.

C-TPAT is a voluntry standard for supply chain security management. CDG helps companies outside geographical boundries of USA to comply with requirements of C-TPAT (Custom Trade Partnership Against Terrorism). CDG is the biggest player in C-TPAT certification in India & neighbouring countries.

The Customs-Trade Partnership Against Terrorism (C-TPAT) is a supply chain security program led by U.S. Customs and Border Protection focused on improving the security of private companies' supply chains with respect to terrorism. This initiative was launched to assist the trading community in the war against Terrorism.

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SA8000 Certification

SA8000 is a social standard developed by SAI (Social Acountability International). SAI is a non governemental, not for profit organisation. SA8000 is an auditable social certification standard which persuades organizations worldwide to develop, maintain, and apply socially acceptable practices in the workplace. SA8000 audit is based on 8 main parameters, which are : Child labour, Forced labour, Remuneration, Working Hours, Discrimination, Disciplinary Action, Freedom of Association & Collective Bargain, Management Commitment. SA8000 certificate describes your CSR & shows your concern towards your workers/employees & community. SA8000 certification process covers all your activities including outsourced process & hence this certification covers workers & working conditions within premices of your subcontractors. CDG is a trusted name in social complince services in India. Contact us for our SA8000 certification services.

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SEDEX Audit

SEDEX - Suppliers Ethical Database Exchange is an association started by global organisations & trade associations. The main function of SEDEX is to develope social standard & ethical practices for organisations worldwide. SEDEX audit covers requirements related to workers & working conditions. This also includes requirements of ILO (International labour organisation) & other labour associations. After SEDEX audit your SEDEX audit findings / reuslt is uploaded on SEDEX website. This audit report can be accessed by members of SEDEX or any other party whome you want to provides access. SEDEX audit is system which decreases number of buyers audit in your organisation. CDG is the most trusted name worldwide for SEDEX compliance.

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BSCI Audit

BSCI - 'Business Social Compliance Initiative' is an initiative to ensure social ompliance of organisations worldwide. The Business Social Compliance Initiative (BSCI) is a leading supply chain management system that supports companies to drive social compliance and improvements within the factories and farms in their global supply chains. In the context of globalisation, retailers, importers and brands source products from supplying companies around the world. Many of them are located in countries where national laws protecting workers are inadequate or poorly enforced. BSCI works to tackle these challenges by offering one common Code of Conductand one single Implementation System that enable all companies sourcing all types of products from all geographies to collectively address the complex labour issues of their supply chain. CDG is a leading BSCI compliance & auditing company worldwide. If your are lookign for BSCI Audit contact CDG today.

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EBC Audit

EBC - Ethical Business Compliance is an initiative of CDG Certification Limited. EBC is a certification standard developed by CDG. This standard focuses on CSR (Corporate Social Responsibility) related activities of an organization. EBC focuses on following points : child labor, forced labor, proper remuneration, proper working conditions, working hours, no discrimination, process of disciplinary action, employees freedom of association, management commitment. EBC is an auditable standard & there is a provision of two stage audit. In stage-1 audit we se adequacy of your social management system as EBC guidelines & in stage-2 audit we see actual implementation level. EBC is getting a global recognition today. Contact CDG for EBC certification services.

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Ethical Trade Initiative

ETI (Ethical Trade Initiative) has been established to improve working conditions in global supply chains by developing effective approaches to implementing the ETI Base Code of labour practice. ETI base code address all issues related to worker’s conditions at work place & their survival issues. ETI base code addresses following issues :-

Freedom in Employment - Slavery or bonded labour is not acceptable.
Freedom of Association & Collective Bargain - Workers should be set free to join trade union for their benefits
Child Labour - ETI do not permit child labour at work place
Living Wages - It is employer’s responsibility to provide wages to workers which should fulfill their basic needs.
Working Hours - ETI do not permit long working hours as it may damage worker’s health & ability to work.
Discrimination - Employer can’t do any kind of discrimination among workers
Regular Employment – It is employer’s responsibility to provide regular employment (throughout the year) to workers to avoid poverty.
Harsh or Inhuman Treatment – ETI provides protection to workers against physical, verbal or sexual abuse in the workplace.

CDG provides training & compliance services for ‘Ethical Trade Initiative’ in India & abroad. If you are planning for ETI Certification / ETI Audit / ETI Membership CDG can be the best pathfinder for you.

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GDP Certification

The wholesale distribution of medicinal products is an important activity in the integrated supply chain management. The quality and the integrity of medicinal products can be affected by a lack of adequate control. To this end, the Commission has published guidelines on Good Distribution Practice of medicinal products for human use. GDP is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs intended for human consumption.

GDP regulates the division and movement of pharmaceutical products from the premises of the manufacturer of medicinal products, or another central point, to the end user thereof, or to an intermediate point by means of various transport methods, via various storage and/or health establishments.

Manufacturers of medicinal products have to make sure that the products will be distributed under controlled conditions. Therefore, wholesalers, transport companies, warehouses and other partners in the supply chain will have to be selected carefully. An ongoing supervision of these organisations is necessary. It is the aim of  CDG to provide a standardized scheme to audit GDP compliance at all levels of the supply chain.

It is the responsibility of the supplying wholesale distributor to protect medicinal products against breakage, adulteration and theft, and to ensure that temperature conditions are maintained within acceptable limits during transport. Wholesalers, transport companies, and warehouses may contact us for a GDP assessment(self assessment) audit. Depending on the size of the organization and their facility we decide audit man-day. CDG is the leading compliance audit company of India providing GDP Compliance assessment services.

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CMMI Certification

Capability Maturity Model Integration (CMMI) is a process level improvement training and appraisal program. Administered by the CMMI Institute, a subsidiary of ISACA, it was developed at Carnegie Mellon University (CMU). CMMI can be used to guide process improvement across a project, division, or an entire organization. With five “Maturity Levels” or three “Capability Levels,” the CMMI defines the most important elements that are required to build great products, or deliver great services, and wraps them all up in a comprehensive model.

CMMI addresses following areas of interest:

  1. Product and service development — CMMI for Development (CMMI-DEV),
  2. Service establishment, management, — CMMI for Services (CMMI-SVC), and
  3. Product and service acquisition — CMMI for Acquisition (CMMI-ACQ).

CMMI was originated in software engineering but it has been highly generalized over the years to embrace other areas of interest, such as the development of hardware products, the delivery of all kinds of services, and the acquisition of products and services

What is CMMI Level?

A maturity level is a well-defined evolutionary plateau toward achieving a mature software process. Each maturity level provides a layer in the foundation for continuous process improvement. In CMMI models with a staged representation, there are five maturity levels designated by the numbers 1 through 5. Initial.

What is CMMI Level 1 ?

At maturity level 1 (CMMI Level 1) processes are usually ad hoc and chaotic. The organization usually does not provide a stable environment. Success in these organizations depends on the competence and heroics of the people in the organization and not on the use of proven processes.

What is CMMI Level 2 ?
At maturity level 2, an organization has achieved all the specific and generic goals of the maturity level 2 process areas. In other words, the projects of the organization have ensured that requirements are managed and that processes are planned, performed, measured, and controlled. At maturity level 2, requirements, processes, work products, and services are managed. Commitments are established among relevant stakeholders and are revised as needed. The process discipline reflected by maturity level 2 helps to ensure that existing practices are retained during times of stress.

What is CMMI Level 3 ?

CMMI Level 3 is one of five “Maturity Levels” in the CMMI. Known as the “Defined” level, CMMI Level 3 is achieved when an organization successfully completes a SCAMPI A appraisal, which verifies that the organization is operating at Level 3. At maturity level 3, processes are well characterized and understood, and are described in standards, procedures, tools, and methods.

What is CMMI Level 4 ?

At maturity level 4 Sub-processes are selected that significantly contribute to overall process performance. These selected sub-processes are controlled using statistical and other quantitative techniques. Quantitative objectives for quality and process performance are established and used as criteria in managing processes. Quality and process performance measures are incorporated into the organization’s measurement repository to support fact-based decision making in the future.

What is CMMI Level 5 ?

At maturity level 5, an organization has achieved all the specific goals of the process areas assigned to maturity levels 2, 3, 4, and 5. Maturity level 5 focuses on continually improving process performance through both incremental and innovative technological improvements. A critical distinction between maturity level 4 and maturity level 5 is the type of process variation addressed. The effects of deployed process improvements are measured and evaluated against the quantitative process-improvement objectives.

What is SCAMPI ?

The Standard CMMI Appraisal Method for Process Improvement (SCAMPI) is the appraisal method that is employed by a Certified SCAMPI Lead Appraiser to help your team “achieve a level.” There are three different types of appraisals, called “Classes” and they are SCAMPI A, SCAMPI B, or SCAMPI C. The SCAMPI A is the only appraisal method that results in a Maturity or Capability Level Rating.

Contact CDG for CMMI level appraisal.

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