GMP Certification

GMP stands for Good Manufacturing Practice, and the term is used globally to manage the control and management of pharmaceutical manufacturing, testing, and overall quality. It defines certain guidelines that discuss the quality assurance approach. GMP certification ensures that products are produced in accordance with quality standards.

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GMP requirements are not unusual in any way; rather, they are open-ended and simple to implement. Furthermore, these requirements allow the manufacturer to decide how to efficiently implement the necessary controls.

GMP Certification Prerequisites

Manufacturing facility design, equipment and machinery design, procedures and operating principles, and environmental conditions must all be controlled.

Manufacturing practices and processes, such as health and safety, maintenance, and so on, must be clearly defined, validated, and controlled to ensure consistency and compliance with specifications.

  • Operators should be aware, trained, and competent to carry out production, QA/QC, Logistics, Factory Management, and product control throughout the manufacturing process.
  • Records should be kept for manufacturing, quality control, and logistics, demonstrating that all steps required by the defined procedures and instructions have been taken.
  • According to regulatory requirements, records should be kept for 5 to 10 years.
  • Supply or sale.

Process of  GMP  Certification 

Application

This is the first step in obtaining GMP certification; the application requests some basic company information. The application must be accepted by the certification authority, and all data must be recorded or maintained in the GMP database.

Application Assessment

The application will be reviewed by the panel to ensure that the consistency requirement has been met.

Analysis and Agreement

After the document audit, provide the value citation to carry out the Gap Analysis to cover all the provisions and areas of the quality rules. The Gap Analysis is used to assess how well an organization's tasks have been organized and completed.

Examining the paperwork

Examine the organization's documentation to ensure that it meets the compliance requirement.

Stage-1

Perform an audit

Determine the consistency required for the documented approach and strategies of your organization

Conduct a poll

Then, review the documentation for your administration structure to ensure that the consistency requirements have been met.

Stage-2

Perform an audit

The inspector verifies that the organization is operating as it should be based on its documentation, the examiner of the authoritative body identifies non-compliances, and finally, the reviewer allows the non-compliances to be corrected. Then, according to the report, evaluate the execution technique.

Corrective Action

Corrective action must be taken if there is any dissimilarity.

Double-check

Your representatives will double-check work instructions.

the documented approach and strategies of your organization

prior to supervising the execution process

Certification is provided.

The Certification Body will issue a compliance certificate that will be valid for an extended period of time.

Surveillance Audit

The purpose of the surveillance review is to ensure that the organization complies with the requirements of the administrative framework. An observation evaluation must be completed every six months or one year after the certificate is issued.

Cost of GMP Certification 

According to the Food and drug administration, the cost of an amendment varies depending on the size of the company (less than 20 employees) and the number of employees (more than 20, but lesser than 500 employees). Typically, it is determined by the size of the company.

Benefits of having GMP Certification

  • and certifying GMP or cGMP can provide a facility/company/organization with the following benefits, among others: Establishes that the organization is adhering to WHO or FDA guidelines, as well as local nationalized standards and guidelines.
  • Maintains hygiene and cleanliness standards throughout the manufacturing and logistics chains.
  • Documents (e.g., manuals, procedures, standard operating procedures, operational controls, risk assessments, regulatory compliances, etc.) and records for evidence are examples of good documentation practices.
  • Design and operation of Medical Devices, IVD products/items, Medicines/Drugs/pharmaceuticals, active pharmaceutical ingredients, Diagnostics products/items, and Food items, including management of processes and products.
  • Establishes personnel competence (including technical competence).
  • Establishes the Organization's system for dealing with Non-Conformities and Complaints, including proper reporting to Regulatory bodies as needed.
  • Reduction Cost reduction and best possible resource utilization
  • Proof of Safe and High-Quality Products and Items
  • All international, national, and local regulations must be followed.
  • Increases customer assurance, rapport, and trust.
  • International Market Entry
  • Within the organization, there is a professional culture.
  • Complaints, fines, product returns, re-processing, rejections, non-conformities, and claims are all reduced.

 How to get GMP Certification 

Certvalue is one of the platforms that coordinate to meet all of your legal and financial needs and connect you to trusted professionals. Yes, our clients are pleased with our legal services. They have consistently regarded us highly and provided regular updates as a result of our focus on simplifying legal requirements.

Our clients can also monitor the progress of our platform at all times. If you have any questions about the GMP Certification process, our knowledgeable representatives are only a phone call away. Certvalue will ensure that your interactions with professionals are charming and seamless. For more details and information visit our official website www.Certvalue.com

PLAN

Conduct Gap Analysis to find any Shortcomings from the standard requirements.
 

DO

Policies, procedures, Work Instructions, Evidences, Records, Training

CHECK

Conduct frequent internal audit and management review meeting.

ACT

Apply corrective actions on the identified root cause or shortcomings

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ISO certification is a tool to streamline and enhance the process performed internal to the organization. Certvalue indulges in inculcating best industry practices.

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It is always about the Brand value of your organization in the market and ISO certification from Certvalue can make your organization to be an excel and stand out in the market globally

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ISO certification is a basic requirement to bid or participate in any tenders floated by government or private sector. And ISO certification from Certvalue is an assurance win over the tenders.

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Sobiya Rajesh
Sobiya Rajesh
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We are happy on Certvalue services. The team guided through applicable SOPs, forms and policies to implement QMS and manage it effectively so as to comply with ISO requirements. It included training part as well. Hence we are satisfied and recommend anyone who seek professional service.
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Certvalue team was very professional in their approach from the time we engaged them. Special mention to Ms. Jeevika Uchil who consulted and worked extensively with our team.
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CyberDome Nigeria Limited. CertValue made the acquisition of our ISO 27100 certification seamless. The person assigned to us Jeevika Uchil was very helpful.
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Shehan Athukorala
Shehan Athukorala
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Certvalue is a very professional and responsive consultation firm. It did show us the right direction towards the ISO and GMP certifications for the PPE devices we are manufacturing. Hoping to work with them for ISO 13485 /CE and FDA as well. Well recommended for all.
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We got good service from certvalue and its team I was satisfied,thank you Certvalue for making my work easy
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Mounika Kona
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Thank you certvalue, we have built information security management system in our organization with the help of certvalue. They were really help to get certified under iso 27001. Thank you.
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somraj daroji
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Very professional in consultation, documentation etc right from the first point of meeting with them. . .thank you certvalue for all the support !
Pushkar Patwardhan
Pushkar Patwardhan
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Certvalue team was very responsive right from the time we contacted them for the first time. Consultants who worked with us were very professional and demonstrated a lot of patience to get us through required documentation / requirments for the certification. Thank you Certvalue!
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