There are three key components that need to be in place for prescription pharmacy manufacturers to financially succeed and sustain brand confidence with key stakeholders – and avoid labeling errors.

These components are essential in order to achieve accuracy, security, traceability and eliminate prescription error within your pharmacy through automation and product lifecycle management.

PRISYM ID recently presented this topic at the Pharmacy Show and received an overwhelming response. Here is our assessment of the three key components to a successful pharmacy:

Compliance to industry regulations will make or break your business! Labels need to be accurate whether manufacturing a batch, patient specific or one off medicine. Potentially fatal consequences can occur due to inaccurate labelling on medicines. Required information includes prescribed dose, route and frequency to be administered as well as possible classification symbols/ pictograms. It is imperative you are compliant with the labelling requirements mandated by the MHRA, NPSA, CLP and GMP.

Strict security processes with multi-user security rights must be in place. The healthcare professional administering the medication is accountable for their actions. If this role is delegated, the primary professional is still responsible for all aspects of the administration, therefore controlling label production with individual user rights is essential to enable complete confidence during and post production.

Product lifecycle management and traceability from preparation to distribution support the compliance and security components.  Implementing a validated system allows insight to information such as what has been done, by whom and when. This valuable real-time information plays a key role in keeping auditors happy and having a successful
pharmacy.

Technology solutions are proven to reduce cost, process overhead, and risk to your business and customers. As well as provide complete traceability and integration with other systems allowing your pharmacy to be more commercially viable.

What methods have you put in place to meet industry regulations and keep your product secure? What do you find to be the greatest challenge with prescription pharmacy manufacturing? Let us know your thoughts below.

Why is it Important?

GMP compliance enforces global quality guidelines for pharmaceutical and medical device manufacturers to follow. The development of automated processes has led to GAMP (Good Automated Manufacturing Practice) which provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. It offers guidance on:

• Adhering to processes that will satisfy the regulatory requirements
• A scalable approach to GxP compliance through the complete lifecycle
• Driving towards a risk based approach
• Effective supplier relationships
• Use of existing documentation and knowledge
• Continuous improvement within QMS
• Quality by design
• Effective governance to achieve and maintain GxP compliance
• Helping bring down the cost of compliance

GMP compliant systems are within any organisation manufacturing and testing with pharmaceuticals and medical devices.  To find out more about the GMP standards and what is GMP ? Visit www.ispe.org for more information.

PRISYM ID has developed PRISYM Medica, PRISYM Pharmacy and PRISYM ClinTrial labelling software as purpose design labelling solutions for Life Science organisations and are supplied as a validated labelling solution including auditable security protocols and lifecycle documentation based on the GAMP V Model.

PRISYM software allows you to design, review, approve, print, reprint and reconcile your labels with the peace of mind that it has purpose built user security, group security and secure audit logging. It can also simply link to ERP and MRP systems to ensure that information from production can be delivered to the label at time of print.

To find out how Prisym ID Software can help you achieve your GMP compliance requirements please contact the PRISYM ID Life Sciences team or leave a comment below.