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GDP compliance (Good Distribution Practice)

Good Distribution Practice (GDP) regulates the distribution of healthcare products from the premises of the manufacturer to the end user and is therefore part of the entire quality assurance process. It ensures that products are consistently stored, transported and handled under suitable conditions as required by the marketing authorization or product specifications during all aspects of the distribution process.

Good Distribution Practice (GDP) is that part of quality assurance which ensures products are consistently stored, transported and handled under suitable conditions as required by the marketing authorisation (MA) or product specification. mostly applicable in pharma industry.
The airline industry is also developing solutions, guidelines, and infrastructure to ensure greater compliance with Good Distribution Practices (GDP) expectations.
Temperature-controlled supply chain challenges when shipping medicinal and healthcare products by air.

Regulatory bodies have become stricter regarding the fulfillment of the GDP regulations like e.g. Saudi Arabia (Statement of the SFDA):

No shipment of pharmaceutical products imported to the Kingdom will be cleared if it was proved that they were transported in non-cooled containers or stored in such a way contrary to the conditions recommended".

The new GDP Guideline will apply not only to the wholesalers and manufacturers of pharmaceuticals, it also incorporates the specific requirements for the Brokers dealing with pharmaceutical products. The responsibility for the product during storage and distribution will remain with the manufacturers up to the point of sale, where wholesale dealers will take ownership of the products. It is clear that those playing a role in the pharmaceutical supply chain must comply with these requirements, therefore the service providers such as transportation companies, the logistic service providers need to gain good understanding of what is required to be able to provide appropriate service to their clients.










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NEWS

  • 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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