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Tag Archives: GMP Certification

Aether Industries Limited has Successfully Completed GMP Certification Audit

 

Aether Industries, a leading manufacturer of advanced intermediates and active ingredients for the pharmaceutical has successfully completed GMP Certification Audit and ISO 9001:2015 Surveillance Audit conducted by UK based ISOQAR Certifying Body with the help of Punyam.com.

GMP Certification

The assessment ensures that Aether Industries’ implemented system continue to meet all elements of the scope of registration and effectively conforms to the requirements set in the GMP and ISO 9001:2015 International Standards.

During this ISO Consultacy for GMP certification audit and ISO 9001 surveillance audit, Punyam.com has helped Aether Industries by checking all the records that all corrective and preventive actions are properly recorded and implemented. The consulting team has helped them to identify risk and internal audit of implemented system based on context of the organization. ISO consultant has taken care of management review and made it easy to compliance during GMP audit and completed without any non-conformity observed.

By this GMP Certification audit taken on 11th December, 2018 by ISOQAR, Aether Industries has been successfully recommended for GMP certification. The project has been completed by Punyam.com within time limits and all documented information was submitted like GMP manual, procedures, work instructions, SOP, Forms and ISO Audit checklist, etc.

About Aether Industries Limited

Aether Industries (based in Surat, Gujarat, India) is a leading manufacturer of advanced intermediates and active ingredients for the pharmaceutical, material science, agrochemical, electronic chemical, and fine / speciality chemical industries. Aether is also a leading CRAMS (contract research and manufacturing services) provider, built upon technology intensive and state-of-art R&D and pilot plant facilities. Aether is based on a core competency model of cutting-edge chemistry and technology competencies.

 

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Announced to Offer Consultancy Service for GMP Certification

Punyam.com, one of the largest ISO Certification Consultancy in India has announced to introduce GMP Certification Consultancy services for Pharmaceutical Manufacturers in India. Good Manufacturing Practice – GMP Certification for Active Pharmaceutical Ingredients (API) ensures that products are consistently produced and controlled according to quality standards without contamination.

Punyam.com has added one more feather to their wide range of consultancy services with aim to provide better system implementation for pharmaceutical manufacturer as per GMP standard guidelines. The experienced team of GMP Consultant of Punyam.com will help in system implementation; provide system awareness and auditor training as well as GMP documentation during this consultancy service.

By join hands with Global Manager Group, Punyam.com has designed and sells ready-to-use GMP Documentation kit to implement fast and effective documentation of quality as well as specific requirements of GMP international standard, which will guide pharmaceutical manufacturer for GMP Certification.

Steps Followed by Punyam.com for Achieving GMP Certification

  1. Micro-level survey for each and every products of the pharmaceutical manufacturer and preparation of detail Gap analysis report,
  2. Preparation of applicable documents required by GMP based on detail study of all activities of the pharmaceutical, such as;
    • GMP Manual,
    • Procedures for GMP Certification (Mandatory procedures required by the standard),
    • GMP Process Approach for various departments of an organization,
    • Standard Operating Procedures (SOPs) for inspection of various activities as well as operation and calibration of identified equipments used in the inspection,
    • Formats to establish the objective evidence of implementation and to ensure control over all the inspection parameter.
  3. GMP training to all levels of employees within the organization,
  4. Helps in effective implementation of system by periodic visit till GMP Certification,
  5. Conduct internal audit to check readiness for the accreditation,
  6. Conduct management review meeting in presence of Top Management to guide the Organization for effective implementation on all the issues,
  7. Conduct mock drill for traceability of product as well as production re-call etc.

 

 
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Posted by on December 27, 2017 in GMP Certification

 

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Punyam.com has Started New Service – ISO 15378 Certification Consultancy

Punyam.com, one of the largest ISO Consultancy Company in India has new service for ISO 15378 Certification Consultancy. ISO 15378:2015 is a standard developed by ISO for primary packaging material for medicinal products manufacturers based on GMP requirements. ISO 15378 certification represents the requirements of quality management system for manufacturers of pharmaceutical and medical device primary packaging materials.

Punyam is offering ISO 15378 certification with system implementation, system awareness training, GMP training, auditor training and as well as ISO 15378 documentation. Punyam has a team experienced ISO consultants who deliver this ISO 15378 certification consultancy services for medical packaging material manufacturers and it will helpful for medical packaging manufacturer in developing their management systems and maintaining their own competence.

Punyam.com has aim to provide effective system implementation with ISO 15378 certification and GMP requirements in India and rest of the world. By join hands with Global Manager Group, Punyam has designed and sell ready-to-use ISO 15378 documentation kit to implement fast and effective documentation of quality as well as specific GMP requirements of ISO 15378 international standard, which will guide organizations management team as well as ISO consultants to offer services in ISO 15378 certification.

Steps Followed by Punyam for Achieving ISO 15378:2015 Certification

Punyam.com, leading ISO 15378 Consultancy in India, is having vast industrial experience in the implementation of ISO 15378:2015 for all types of Pharmaceutical and medical device manufacturer. Punyam implements the ISO 15378 system for its customers in the following manners;

  1. Micro-level survey for each and every medicinal products of the pharmaceutical and medical device and preparation of detail Gap analysis report,
  2. Preparation of applicable documents required by ISO 15378:2015 based on detail study of all activities of the medical device, such as;
    • ISO 15378 Quality Manual,
    • Quality Procedures for ISO 15378:2015 Certification (Mandatory procedures required by the standard),
    • Standard Operating Procedures (SOPs) for inspection of various activities as well as operation and calibration of identified equipments used in the inspection,
    • Formats to establish the objective evidence of implementation and to ensure control over all the inspection parameter.
  3. Preparation of Quality assurance plan for maintaining and assuring quality of inspection services provided to its customer.
  4. ISO 15378 training to all levels of employees within the medical device.
  5. Helps in effective implementation of system by periodic visit till accreditation.
  6. Conduct internal audit for ISO 15378 system to check readiness for the accreditation.
  7. Conduct management review meeting in presence of Top Management to guide the Inspection bodies for effective implementation on all the issues related to management requirements and technical requirements.
 

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