Why records management is critical for pharma companies

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Why Records Management is Critical for Pharma
companies?
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Introduction

• Your records room operations are direct evidence
  to the fact that you follow the GMP processes
  rigorously.
• If your records room operations are not as per
  Record Keeping and Record Management Practices in
  GMP then it could lead to losing your FDA license
  and lawsuits because of defective products,
  possible recalls, and harm to patients.
• Ultimately harming your organisation which can be
  easily avoided by following best practices for
  records management.
• If it isnt documented, it wasnt done! You must
  have heard it many times in your career.
• In a records room, a direct corollary to the
  above statement is this If it cannot be found,
  it never existed! This is exactly true for any
  documents that get lost in your organisation.
  Your auditors will not be happy if you are not
  able to provide the records they are looking for.

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What has Records Management got to do with GMP?

• The following are the most notable and most
  frequently referenced
• The US Current Good Manufacturing Practices for
  Finished Pharmaceuticals regulations (the US
  cGMPs)
• The Guide to Good Manufacturing Practice for
  Medicinal Products of the European Union (the EC
  GMP Guide)
• The ICH Q7 Good Manufacturing Practice Guide for
  Active Pharmaceutical Ingredients
• Schedule M Good Manufacturing Practices and
  Requirements of Premises, Plant and Equipment for
  Pharmaceutical Products, The Drugs and Cosmetics
  Act and Rules, India.
• The World Health Organization (WHO) good
  manufacturing practices.

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The 10 Golden Rules of GMP

• Get the facility design right from the start
• Validate processes
• Write good procedures and follow them
• Identify who does what
• Keep good records
• Train and develop staff
• Practice good hygiene
• Maintain facilities and equipment
• Build quality into the whole product lifecycle
• Perform regular audits

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Importance of Record Keeping

• The manufacturing and testing records (along with
  product retention samples) are all that remain
  once a batch is released.
• Document management software is used to manage
  record keeping.
• These records are the only real source of
  information on a batch after it has been
  released, so they must be accurate and complete.
• They provide legal evidence that the company
  followed GMP.
• There are many cases where in a legal dispute,
  the GMP-related records are used in court to
  verify that the company followed GMP.
• They are used to investigate product
  complaints/adverse events.
• Complaint investigation is a critical activity to
  protect patients health. If the records are not
  accurate and complete, incorrect conclusions may
  be made about the problem.

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DocPro

• DocPro is suite of products for Document
  Management, Workflow Management, Accounts Payable
  Automation, Records Management, Document
  Processing and Digitization.
• DocPro empowers business organizations get a
  complete control over their business processes
  related to their digital or physical documents
  and their storage, retrieval, access control etc.
  
• After many years of providing document management
  services to our clients, we transformed ourselves
  into a document management company by developing
  the DocPro suite.
• DocPro is currently being used in Telecom, BFSI,
  Defense and Government Organizations

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DocPro
For more details of Records Management visit to
Why Records Management is critical for Pharma
companies