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Category Archives: GMP Certification

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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