UNIT II PHARMACEUTICAL QUALITY SYSTEM Flashcards
• Effective quality management system for the pharmaceutical industry
• Comprehensive model based on ISO quality concepts
• Includes cGMP, complements ICH Q8 (Pharmaceutical Development) and ICH Q9 (Quality Risk Management).
ICH Q10-Pharmaceutical Quality System
AREAS OF PHARMACEUTICAL QUALITY SYSTEM:
Quality Risk Management
Contamination/Cross Contamination
Good Documentation Practice
Good Quality Control Laboratory Practice
Self-inspection
Continuous Improvement
A systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle
QUALITY RISK MANAGEMENT
Risk Management Process:
- Identify the Risks
- Analyze the Risk
- Evaluate or Rank the Risk
- Treat the Risk
- Monitor and Review the Risk
CAUSE AND EFFECT METHOD Fishbone
Fishbone (Ishikawa) Diagram
CONTAMINATION/CROSS CONTAMINATION PREVENTION
N/A
An impurity or any substance or material that causes contamination or spoilage.
Contaminant
The undesired introduction of impurities of a chemical or microbiological nature or of foreign matter, into or on to a starting material or intermediate during production, sampling, packaging, repacking, storage, and transport.
Contamination
Contamination of a starting material, intermediate product, finished product with another starting material or a product.
Cross-Contamination
SOURCES OF CONTAMINATION/CROSS
CONTAMINATION:
Microbial Contamination
1. Facility
- Flow of Personnel
- Materials
-HVAC
-Waste
2. Equipment
- Assembly Cleaning Sterilization
3. Process
- Open Vs. Closed
4. Materials
- Raw material Reusable resin & Membrane filter
5. Utilities
- Water Gases
6. Personnel
SOURCES OF CONTAMINATION/CROSS
CONTAMINATION:
Premises and Design of Building
Equipment
People
Heating Ventilation and Air Conditioning (HVAC) System
Manufacturing
Clothing and Footwear
Written procedures for a laboratories program.
They define how to carry out protocol specified activities.
Most often written in a chronological listing of action steps.
They are written to explain how the procedures are supposed to work.
Standard Operating Procedures (SOP)
An approved instruction either in paper or electronic form which guides about how an activity shall be executed.
Documents
provide evidence that activities have been performed or results have been achieved.
A_____ is often considered as document.
They always document the past.
Records
What is Good Documentation Practice:
Documentation must be;
Accurate : true / precise, error free,
Concise: short & clear information that is understood by all
Legible: shall be readable, understandable.
Traceable: who recorded it, where, when and how
Contemporaneous: documented at the time activity done
Enduring: Long lasting and durable
Accessible: Easily available / retrievable
Shall be Complete & Authentic:
Principles of GDP:
A document with original signatures should never be destroyed.
Never falsify information
Never do white-out and cover-over-tapes
Never obliterate information or record Never over-write a record.
Never use pencil - use permanent ink for writting
No spaces, lines or fields are to be left blank Never use symbols e.g ditto marks or arrows to indicate repetitive and consecutive entry
Observations on Poor Documentation Practices
Missing signature and dates at the time of activity performed.
Non-uniform date and signature
Activity was performed & writing on one day and signed on another day.
Blank spaces
Illegible writing
Too many corrections
Write-overs, multiple line-through
“White-out” or other masking device
Error correction not signed/dated, and reason for the correction not written
Not traceable
Data integrity
Benefits of GDP
Compliance to regulatory requirement- No observation / warning letters/Import Alert/ ban
Build confidence on System & practice
Correct, complete, current and consistent information Effectively meets customers and stakeholders’ requirements.
Ensure the traceability
Useful for review; investigation & CAPA
Solve complicated problems
Reduce or eliminate assumptions and second-guessing.
Eliminate the need to re-ask the same questions
Specify clear instructions to staff
Consistent quality, yield and performance of staff.
GMP- Documentation Requirements
•Keep in mind, after the product is released and shipped to the customer, what remains behind is the Document.
Documentation/record is useful to us ONLY if it is 100% accurate.
So it is important for us to understand and follow the Good Record Practice.
Why do people sometimes fail to document activities or events properly?
People don’t clearly understand what or when to document.
Procedures may not be completely understood or followed.
People aren’t always held accountable.
People will make mistakes.
People don’t always make corrections properly.
People do not relate records to auditing.
People don’t understand the legal role of documentation
Record Keeping System
How do maintain the record?
Bound notebook pre-numbered
loose sheets (Pre-numbered, the printing have to be controlled and also the storage as control records)
Every register Forms shall have
- Format/control number/header
- Date of opening
- Date of closing
- Table of content where applicable
Record Writing/Data Entry
Enter complete and accurate information at the time work is performed.
Enter signature or initials (according to procedure) When one or more person complete the task, all person must sign.
Never sign your name for performance of a job for work actually performed by someone else.
Limit the use of abbreviations and acronyms.
Use a non-water-soluble pen for writing on any official document.
Use Ball point pens of blue or black colored inks to make entries.
Don’t use pens like gel pens, ink pens for making entries.
Don’t use pens like red, green color ink.
Spaces and cells cannot be left “blank”!
When spaces or cells do not contain information, EACH must contain the appropriate “not applicable” entry. Or N/A
This rule applies to all product-related documents - electronic and written.
× Never use ditto
× Never use lines (with or without arrows) to show a continuation of values or entries in a column or row.
Corrections to written records must be made properly.
* NEVER mask the original entry.
* NEVER USE “correction” liquid, tape, or material.
Corrections to written records must be made properly.
X DO NOT USE “write overs” (Don’t turn a “6” or “9” into an “8”.)
X Never vary your initials or signature
How to properly make corrections:
When an entry or calculation must be corrected, follow these steps:
*Draw a single line through the incorrect entry. *Enter correct information above or to the side of the incorrect entry.
•Write your initials and date of correction. Write justification if possible •When two people signed the original entry, and then another changes the entry, the second person must also sign for the change.
Draw a single line through the incorrect entry.
Enter correct information above or to the side of the incorrect entry.
Write your initials and date of correction. Write justification if possible
When two people signed the original entry, and then another changes the entry, the second person must also sign for the change.
Don’t deface the original entry!!!
GDP Error Description
The following are the example of notations that may be used to describe error corrections.
Calculation error
Transposition
Illegible entry
Wrong entry
Clearly Record the Data
