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PS 90001

PS 9000 manufacturers of packaging material for medicinal product

PS 9000 was developed by the Pharmaceutical Quality Group (PQG) for manufacturers of packaging material for medicinal product and now orally inhaled medicine, with reference to Good Manufacturing Practice (GMP).
Its primary objective is to facilitate risk management and implementation of a controlled system to eliminate these risks to ensure production of safe products to correct requirements.
The standard is aligned to ISO 15378 (Primary packaging materials for medicinal products) and based on these principles as well as ISO 9001. Fully recognised and supported by the MHRA, it incorporates many quality management principles in line with GMP and regulatory requirements.
The 2011 revision has added focus on electronic origination and controls and the interface with production throughout all process steps, as well as ensuring the importance of controls in terms of traceability and verification of materials throughout the process chain.

It is an interactive standard that can be applied to Global, Primary, Secondary and Complex manufacturers, each with specific requirements. How can PS 9000 benefit my organisation?
PS 9000 is a standard relevant to all parts of the pharmaceutical industry supply chain, allowing shared knowledge, practices and implementation to manage risks and safeguard the well being of people and business.
Whether a contractual need or simply looking to reduce overall risk to your organisation and products, there are a number of key benefits to implementing a certificated PS 9000 system.
Quality Controls - Clear implementation of practices across production process including electronic interfaces to assure quality products, fit for purpose and minimising counterfeit medicines

1- Personnel/Communication - More clearly understand roles and responsibilities in terms of producing quality products
2-GMP - Incorporation of specific Good Manufacturing Practice requirements which assure material are appropriate quality and correct procedures are followed in terms of checking, traceability, contamination and hygiene controls

3- Risks - Structured approach to risk management and key focus on risk areas associated with packaging operations, with effective controls and activities detailed, which ultimately helps to reduce potential product and business issues

4-Compliance - Used in support of regulatory compliance and identification of appropriate legislation
5-Harmonisation - Helps integration of Regulatory, Quality and GMP requirements
6-Commitment - Organisations need to show their compliance with all relevant statutory and regulatory pharmaceutical packaging safety and GMP requirements in addition to their own policies

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  • As part of updating its registry, MCA would be conducting KYC of all Directors of all companies annually through a new eform viz. DIR-3 KYC to be notified and deployed shortly. Accordingly, every Director who has been allotted DIN on or before 31st March, 2018 and whose DIN is in ‘Approved’ status, would be mandatorily required to file form DIR-3 KYC on or before 31st August,2018. While filing the form,the Unique Personal Mobile Number and Person

  • Forms MGT-7, AOC-4 and Additional Attachment are likely to be revised on MCA21 Company Forms Download page w.e.f 14th JULY 2018. Stakeholders are advised to check the latest version before filing.

  • DIR-3 KYC will be available on MCA21 Company Forms Download page w.e.f 14th July 2018 for filing purposes. Stakeholders are advised to plan accordingly.

  • MCA21 system will be intermittently unavailable from Saturday, 23rd June 2018 09.00 pm to Saturday, 23rd June 2018 11.00 pm IST due to maintenance activity. Stakeholders are requested to plan accordingly.

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