Transcript
GOOD DOCUMENTATION AND QUALITY MANAGEMENT PRINCIPLES
Vimal Sachdeva Technical Officer (Inspector), WHO Prequalification of Medicines Programme
Contents 1. Why good good doc docum ument entati ation on is ess essent entia ial? l? 2. What What consti constitu tutes tes good good docum document entati ation? on? 3. Qual Qualit ity y mana manage geme ment nt 4. Devi Deviat atiion cont contro roll 5. Change nge co control trol 6. Risk isk man manage ageme men nt 7. Prod Produc uctt qua quali lity ty revi review ew 8. Summary
Contents 1. Why good good doc docum ument entati ation on is ess essent entia ial? l? 2. What What consti constitu tutes tes good good docum document entati ation? on? 3. Qual Qualit ity y mana manage geme ment nt 4. Devi Deviat atiion cont contro roll 5. Change nge co control trol 6. Risk isk man manage ageme men nt 7. Prod Produc uctt qua quali lity ty revi review ew 8. Summary
Why Good Documentation is essential?
An essential part of the quality assurance system and should exist for all aspects of GMP (reference: WHO GMP, Volume 2)
Good documentation practice is an expected practice!
Correct, complete, current, and consistent information effectively meet customer and stakeholder' requirements
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 its 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.
Quality Management
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".
Quality Management
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, vendors qualifications using appropriate risk management tools.
Deviation control
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, equipments, 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 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.
Change request form
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.
Quality Risk Management
Quality Risk Management The main risk management process includes: •
Risk assessment
•
Risk control
•
Risk review
•
Risk communication
Overview of a typical quality management process
Ref: ICH Q9
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:
Scientific knowledge and
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
Product Quality Review
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 Control Chart Worst Case Upper Spec (Acceptance) Limit Control (Action) Level
X X
X X
X
X
X
X
X X
X X X
X
X
X X X
X X X
X
Target Control (Action) Level Lower Spec (Acceptance) Limit Worst Case
Time
X = average of a set of observations
Example of control chart-2
Process Capability Capability Value (CP or CPK)
Translate into
< 1.00
Process is not capable
1.00 to 1.33
Product is barely manufacturable
1.34 to 3.00
Process is a good one
>3.00
Process is excellent
Ref: Establishing the Minimum Process Capability for a Drug-Product Manufacturing Process – Dr Paul King.
