GOOD DOCUMENTATION AND QUALITY MANAGEMENT PRINCIPLES
Contents
1. Why good documentation is essential?
2. What constitutes good documentation?
3. Quality management
4. Deviation control
5. Change control
6. Risk management
7. Product quality review
8. Summary
Why Good Documentation is essential?
1.An essential part of the quality assurance system and should exist for all aspects of GMP
(reference: WHO GMP, Volume 2)
2. Good documentation practice is an expected practice!
3.Correct, complete, current, and consistent information effectively meet customer and
stakeholder' requirements
4. Helps to reduce observations raised on inadequate documentation practices.
What constitutes Good Documentation?
Approve, review and update documents
Changes & current revision status of documents identified
Relevant versions of applicable documents available at points of use
Documents remain legible and readily identifiable
Documents of external origin identified and their distribution controlled
Prevent unintended use of obsolete documents, and archiving.
Observations on poor documentation practices
Document error correction not signed/dated, and didn’t include a reason for the correction
Write-overs, multiple line-through and use of "White-out" or other masking device
Sample sequence table and audit trail not documented (if it’s not documented, it didn’t happen)
SOP related to production, calibration, storage and maintenance not authorized by the QA head
The delegation for the batch release, in case of absence of the QA manager, not recorded /
documented
Out-of-specification (OOS) procedure not detailed enough; flow chart and /or check-list not
available.
How are mistakes corrected?
Draw a single line through the error
Make the correction next to the error
Write an explanation for the error
Sign and date the correction.
Some tips on Good Documentation Practices
Records should be completed at time of activity or when any action is taken
Superseded documents should be retained for a specific period of time
Records should be retained for at least one year after the expiry date of the finished product
Concise, legible, accurate and traceable
Picture is worth a thousand words
Clear examples
Don’t assume knowledge.
What is Quality Management
• An appropriate infrastructure or "quality system", encompassing the organizational structure,
procedures, processes and resources;
• Systematic actions necessary to ensure adequate confidence that a product (or service) will
satisfy given requirements for quality. The totality of these actions is termed "quality assurance".
Considerations for Quality Management
To incorporate an approach to doing business that stresses building in quality through techniques
such as:
design controls, continuous improvement, auditing, management review and risk management.
To incorporate a robust quality system encompassing good documentation practices, including
but not limited to:
handling of complaints, recalls, change controls, deviation controls, vendor’s qualifications
using appropriate risk management tools.
What is a deviation?
A departure from standard practices or specifications resulting in non-conforming material / or
processes, with potential to impact on product quality, safety, efficacy or data integrity.
Planned and unplanned deviation
Different levels of deviation: critical, major, minor
How to manage deviations?
Regulatory requirement to capture all sorts of deviations evolves in order to maintain the
continuous improvement of processes and systems
All batch production deviations (planned or unintended) covering all manufacturing facilities,
equipment’s, operations, distribution, procedures, systems and record keeping should be reported
and investigated for corrective and preventative action (CAPA)
Deviation should be documented when there is a deviation from methods or controls in
manufacturing documents, material control documents, and/or standard operating procedures.
Considerations for Deviation Management
Develop policy on deviation
Determine approach i.e. differentiation among various deviations
Tracking of deviation
Trending of deviation
Create database (software based or manual system) to assist in tracking and trending of
deviations.
Change control
Change: any modification to product, document, process, equipment, instrument, system,
facility etc. Change control: procedure reviews, verifies, regulates, manages, approves and
controls changes made to the existing operating system or facility or process or procedure or
document or product of any combination The key principles of change control are understanding
and documenting:
What was done, why, when, where, by whom, how and Results, including the impact of
changes to other processes.
How to manage change control Written procedures should be established and maintained to
control changes for:
Processes, Facilities, Utilities
Methods, Validation, Computer systems
Training and training materials
Regulatory filings and Quality Systems Changes should be justified and documented. All
changes that have the potential to impact the quality, safety and efficacy should be evaluated,
reviewed and approved.
Flow chart of Change control
Considerations for Change control
According to the nature and extent of the changes, and the effects these changes may have on
processes & products:
Realistic and based on the risk (critical, major and minor) associated with each change
SOP on change control should provide as many examples / scenario as possible for the various
changes Impact assessment following implementation of each change
Approval from the respective regulatory authority on the changes which has direct impact on
the quality, safety and efficacy
Tracking to manage all types of changes
Periodic review should be done on all changes taken place.
Conditions to Change control
Revalidation
Requalification
Increased testing
Stability analysis
Document change
Regulatory action / variation application.
Conditions to Change control
Revalidation
Requalification
Increased testing
Stability analysis
Document change
Regulatory action / variation application
Quality Risk Management
Quality Risk Management The main risk management process includes:
• Risk assessment
• Risk control
• Risk review
• Risk communication
Considerations for Quality Risk Management
No guidance documents specifying what documents and records must be kept by an organization. Our
expectations are to scrutinize processes, products, materials, vendors, equipment, facilities, distribution
systems using appropriate risk management tools. Following documents and records should at least be
available to support a risk management program: policies, procedures, analysis-specific plans, records
and reports.
Considerations for Quality Risk Management-2
Evaluation of the risk to quality should be based on:
1. Scientific knowledge and
2. Ultimately link to the protection of the patient The level of effort, formality and documentation should
be commensurate with the level of risk. Note: WHO Guideline on Quality Risk Management
What is Product Quality Review (PQR)?
"Regular evaluations of the quality of pharmaceutical products should be conducted with the objective of
verifying the consistency of the process and ensuring its continuous improvement (WHO GMP 1.2/l)".
"Regular quality reviews of APIs should be conducted with the objective of verifying the consistency of
the process. Such reviews should normally be conducted and documented annually and should include at
least a review of…. (WHO GMP for APIs 2.5)". The EU PQR requires a greater number of items and
areas for review as compared with the US product annual review (PAR). Note: A detail section on PQR
(similar to the EU GMP) has been included in the revised Annex 3, WHO GMP Guide.
Considerations for PQR
The PQR should be written in a common language (e.g. English) which must be understood by all the
parties involved.
The procedure for performing a typical product review involves the review, analysis, and trending of
historical data (i.e., data generated in the past 12 months).
Data generated from the batch or product should be trended using appropriate statistical techniques
(control charts, process capability study) to determine if the process is in control/capable and any need to
make changes.
Based on the review, an assessment be made whether corrective and preventive action (CAPA) or any
revalidation be undertaken, and the same should be completed in a timely and effective manner.
Example of control chart-2
