Getting GDP Certification in Canada is a great way to show that you are committed to keeping your products and services in line with the regulatory requirements. These requirements are outlined in the GDP Guidelines, which focus on the wholesale distribution of medicinal products. In addition to the required mandatory inspections and audits, some additional requirements must be met. These include documentation, induction and subsequent training, and intervals between inspections.
Major requirements of GDP Certification in Canada
Documentation required
Whether you are a manufacturer, wholesaler, or transport company, you must comply with GDP Certification in Canada. Keeping up with these guidelines can be challenging, especially if you are a wholesale dealer. However, with the help of Factocert’s GDP Consultants, you can be confident of quality in all areas of your business.
Aside from complying with national legislation, you must ensure that your organization has a well-established quality system. This includes a documented quality policy and authorized procurement procedures. In addition, you need to establish corrective and preventive actions. These measures must also ensure that your records are accurate and in compliance with GDP standards.
For certification, you need to undergo an inspection by a competent authority. The results of the inspection must be reported in a report. The document must be submitted to the company for approval. If the inspector accepts the distributor’s response, the MHRA will issue a GDP certificate.
Intervals between inspections
EFPIA, the European Federation of Pharmaceutical Industries and Associations, has been conducting an annual survey on GMP/GDP inspections since 2003. The results of this survey are available on the organization’s website. The survey is designed to provide member companies with an objective assessment of state of the art in health authority inspections. The survey is conducted in a manner that allows member companies to compare their inspection statistics with those of similar size and industry groups.
The survey focuses on duplicate inspections, the number of inspections performed at each site, and the most common inspections performed on the company’s facilities. These data points are of interest to both the company and the regulatory authorities. The survey also measures the efficacy of regulatory activities, whether the regulatory process is efficient, or if there are bottlenecks and roadblocks.
Outsourced activities covered in an internal audit program
Performing an Internal Audit of Outsourced Activities can be quite complex. It requires you to understand the nature of outsourced work and the associated risks. You need to identify the key IT management activities and their effectiveness, assess the impact of outsourcing on your business and take the appropriate corrective actions.
Outsourced activities should be a part of an overall Quality System. The system should include a quality agreement between the parties, which specifies the roles and responsibilities of both parties. It should also include a Quality Manual and written procedures.
A Quality System is important as it outlines all distribution activities for medicinal products. The system should include a responsible person to ensure compliance with the GDP. This person should be well-trained and competent and follow a written training program.
Induction and subsequent training are required
Medicinal products manufactured or supplied in the EU must comply with Good Distribution Practices (GDP). It’s a set of rules designed to reduce the risk of misdirection or misuse of products. GDP Certification in Canada is a set of guidelines covering medicines’ storage and transportation.
While the requirements of the GDP Guide are not very specific, they still require a comprehensive training program. Fortunately, eLearning is an option. The GDP Association has created an online course that explains the principles of GDP Certification in Canada and what it’s for. It’s aimed at existing staff and is also available to new starters.
GDP Certification in Canada is defined as the Compilation of Community Procedures on Inspections and the Exchange of Information. It contains a list of competent authorities.
GDP Guidelines focus on the wholesale distribution of medicinal products
Good Distribution Practices (GDP) regulates medicinal products for human use. These guidelines ensure that medicines are transported and stored safely. The regulations apply to all supply chain stages, from production through to the consumer.
The EU issued a new version of GDP Guidance, enacted on 8 September 2013. These guidelines aim to preserve goods in the distribution chain and provide wholesalers and other actors involved in distributing medicinal products with guidance on how to conduct their activities. The revised guidelines include general provisions and supplementary requirements.
To comply with the regulations, organizations wishing to distribute pharmaceuticals in the European Economic Area must hold a wholesale distribution license and obtain a GDP certificate from an EU competent authority. In addition, manufacturers of medicinal products must follow Good Distribution Practices.
