Standard Operating Procedures (SOPs) are critical for any company operating within a regulated environment.  However SOP non-compliance or deficiencies are still one of the most common audit or inspection findings made by auditors or regulatory inspectors, respectively.  Typically these findings could be avoided if the company had higher quality SOPs.  Common pitfalls of SOP development include; the writing style used was not reflective of the SOPs’ target audience; inappropriate SOP author was selected; duplication or contradiction of the SOP content within the SOP or with other SOPs; and SOP presentation errors.  SOPs also tend to evolve over time in a company and as such they are at risk of being adapted so that they become out-dated with current regulatory requirements, actual processes followed in the company or become too prescriptive as a result of previous problems experienced by the company.  When developing or reviewing one or more SOPs, the company must consider the personnel time resource, experience, business risk (reputation, liability), safety risk of trial/study subjects and cost implications.  They must also assess whether SOP development should/could be outsourced to an external provider or whether this could be conducted internally.

Some of the challenges faced by an external provider are that the external provider does not have in-depth knowledge of the company structure, existing SOPs, processes and culture, and so the company must be prepared to share this information with the provider once a confidentiality agreement is in place.  Lastly, the review process for an SOP developed externally may also take slightly longer than an internal review, but this will depend significantly on the complexity of the review process.

There are however many benefits to using an external provider.  Typically an external provider has had exposure to several different styles of SOPs and Quality Management Systems and so are able to use this experience to adapt or create SOPs which will fit regulatory needs.  In addition, the external providers experience can be very useful to a company if they wish to develop a process for which the company has no or limited experience, for example if the process is to be used in a new geographical location or environment.  The external provider can have the benefit of naivety to the existing processes and influence of company culture, and so it can be easier for them to identify gaps or flaws in the described processes.

The ADAMAS Corporate Brochure 2016

 

Brochure – Please download the ADAMAS brochure describing our QA services and contact details.

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Regulatory Environment

 

The development of medicines is the most regulated industry in the world, and compliance at each stage of the research and development process, as well as after licensing, is critical to ensuring high quality and safe medicines reach patients in a timely manner.

adamas-quality-assurance-services

 

ADAMAS’s consultants have expertise across the G’X’Ps in pre-clinical, clinical and post-licensing areas. They have worked across many different therapeutic areas and product types including oncology, vaccines, biologics, medical devices and gene therapy. As a company we have developed close partnerships with our clients to support them in their development programmes and post-licensing activities, and to guide them successfully through their worldwide regulatory inspections.

 

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How to be a Clinical Auditor

 

‘So you want to be a Clinical Auditor?’, an article written by CEO Dr. Patricia Fitzgerald.

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Benchmarking Data

 

Please download our benchmarking data sheet, to see how these data compare with your own performance. To discuss a more detailed report, or analysis of a data subset, please get in touch.

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Is your QMS compliant?

 

Is your QMS compliant to the upcoming ICH E6 Addendum? Download our 5-point checklist

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ICH (E6) R2 Addendum - Step 4

 

Please enter your details to complete the download.

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