23 June 2022

Gap analysis of quality management system in GMP environment

With many years of experience in GMP projects, Billev Pharma East experts can accurately identify defects and deviations in GMP systems and provide gap analysis reports and lists, suggestions for corrective actions and prioritization of identified gaps. In addition, Billev Pharma East can provide corrective support, progress tracking, on-site guidance or GMP inspection support to ensure the project being completed efficiently and qualitatively.

Maintaining quality management system (QMS) with current legislation requirements should be the goal of every manufacturer of pharmaceuticals. When a new guidance or legislation is released, companies will usually have a grace period to ensure they are allotted enough time to ensure full, updated compliance. A thorough and detailed review of the current QMS as well as deficiencies in compliance with newly released regulatory standards, a GAP analysis, is highly suggested.

A GAP analysis is a detailed review of a QMS, including but not limited to, all levels of documents from manuals to templates to records. A GAP analysis assesses the competency of a current QMS and how it adheres with the requirements of a standard, legislation, or regulation. A GAP analysis consists of thorough documentation of where a QMS is in terms of compliance and what changes it requires to maintain full compliance. A GAP analysis is highly recommended for an existing quality management system (QMS), as it doesn’t require the full rework of an entirely new system, but rather introduces the changes necessary to update the QMS.

A GAP analysis can not only speed up compliance with a new standard, legislation or regulation, but can also save a lot of expenses involved in failing an audit or inspection. GAP analysis is a way to compare current conditions and practices in order to identify gaps and areas in need of improvement with regards to compliance with the relevant standards and legislation. GAP is used by all the pharmaceutical companies to analyse processes of any division of their company; quality management process, internal communications process, document control process, record keeping process, training process, internal audit process, management review process, measuring and monitoring process, non-conformance management process, and continual improvement process.

What are the two main goals of a any GAP analysis:

  • to identify and demonstrate areas of compliance;
  • to find the gaps between the process and the regulatory requirements they are being compared against.

A gap exists where existing policies, processes or procedures do not fully meet the stated requirements. A gap analysis checklist should be used to capture the gaps in your organization’s management system and the reference requirements, with the goal of determining:

  • what existing company processes and procedures already meet the requirements;
  • what existing procedures and processes need to be modified to meet the requirements;
  • what additional procedures and processes need to be created to meet the requirements.

After the GAP analysis, company should have a clear picture of how existing QMS compares with the requirements. In general, the steps for conducting a gap analysis are:

  • reviewing what is the present operation/process and what already exists;
  • analysing the relevant sections of the Standard/Guidelines/requirements to determine what is actually required;
  • documenting the differences or gaps.

These differences and gaps should be organized into a detailed findings list, for review and approval by top management. In summary, the gap analysis should include a review of all processes and procedures for management controls and technical controls, such as for sampling, method validation, equipment calibration, qualification and maintenance, employee qualifications, and other. The knowledge obtained about the status your existing quality management system will be a key driver of the subsequent implementation approach. Not only will a gap analysis help to identify the gaps, it will also allow to recommend how those gaps should be filled. The gap analysis output, in the form of a findings list provides a valuable baseline for the implementation process, and for measuring progress.

In closing, the GAP analysis is a singular tool used in the overall maintenance of a quality system. Its actions and performance can be compared to a simplified type of audit, but the GAP analysis itself is not going to replace your regularly scheduled audit activities. However, it will help you monitor and keep overview on the overall pulse of company QMS. This is also especially helpful in situations where standards, legislation and regulations are updated, and QMS needs to be evaluated and updated accordingly.