Steps in Analytical Method Validation

Analytical Method Validation

Quality Audit Frequency and Audit Schedule

Depth And Duration Of Quality Audit: It usually depends on the following parameters.

• Objectives status and history of organization.
• Complexity and size of organization.
• Number of audit criteria.
• Amount of human and financial resources.
• Amount of time and expertise of auditors.

Frequency of Quality audit:

• To optimize the control of significant quality aspects.
• High risk areas are audited more frequently.

Quality Audit Schedule:

• It clearly identifies objectives, criteria, scope etc.
• It contains audit details, site information, date and duration of audit, proposed activities documents required etc.
• Resulting in greater chances of audit to become more valuable and cost effective.

Notification of Audit:

• Announcement encourages the organizational units to correct many things in advance on their and set their house in order. Units are noticed in advance so that it may be likely that performance of the audit smoother and fruitful.

Difference between Internal quality audit and External Quality Audit

Difference between Internal Quality Audit and External Quality Audit are As follows , So let us check it out one by one.

• Internal: Is examination of quality system and procedures in organization "First party audit"
• External: Is an evaluation of suppliers, contractors etc., "Second or Third Party Audit"

• Internal:Performed by team drawn from different departments i.e, production , QC, QA etc. is put together design.
• External: Performed by consultant professional test implement the associations and of course regulatory who are not party to supplier or customers.

• Internal: Employees may or may not contribute new information and knowledge.
• External: Contribute lot of information to employees.

• Internal: Conducted at reasonable internal with covering all areas of function / operations and hence it is very effective to determine non complying activities.
• External: Conducted infrequently with examine small parts of Productions, Operations and hence ineffective to determine all non complying activities.

• Internal: Carried Out by people within organization, they are likely to miss out most obvious mistakes.
• External: Outsider with fresh approach for inspection , they are less likely to miss out most obvious mistakes.

Types of Quality Audit

Adequacy Audit or Document Review:

• System or management audit.
• Determine the extent to which document system represent by the quality manual and procedures meets the requirements of applicable standards.

Compliance Audit or Onsite Audit:

• Seeks to establish the extent to which the documented system is implemented and observed by workforce.

External Audit:

• Performed by company on its own suppliers.
• It may be an adequacy or compliance report.

Internal Audit

• Most important and requires to look on own system, procedures and activities in order to ascertain whether it is adequate and complied with it.
• It provides management with information whether their policies are meet or not.
• It provide line of communication throughout the company.

Quality Audit Objectives

Objectives of Quality Audit Is:

• To determine conformity or non conformity of quality system elements with specified requirements. 
• To suggest corrective actions and also to permit regular review of status of implements in an impartial manner in order to encourage and improve the quality of work in all the areas of manufacturing in order to meet standards laid down by regulatory agencies.
• Also to determine effectiveness of implemented quality system in meeting specified quality objectives.

Scope of Quality Audit Is:

• All operations directly or indirectly connected with manufacturing are covered thus personnel, premises,  Warehousing, Dispensing, production, packaging, quality control, engineering, environment, personnel safety and document should be covered.

Principles of Quality Audit:

• Ethical Conduct
• Fair presentation
• Due professional care
• Independence
• Evidence based approach

What is Quality Audit

Quality Audit can be defined as : "A systematic and independent examination to determine or check whether the quality activities which are performed and the related results comply with the planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives."

The main objective of audit is that it checks the compliance with planned arrangement and implementation.

It is one type of an information gathering activity by the auditors for making improvement and corrective action.

The audit which is performed may be Internal or External and do not necessarily have to cover the whole system at once but it may cover some of the elements of the system.

The first party audit is an audit carried out by an organization itself which is known as Internal Audit.

A second party audit by one organization , working on its own behalf , on another i.e, audit on supplier by a customer

Third party is an audit by independent organization on supplier.