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Specifications
• Specifications are the quality targets to achieve• Specifications describe the quality parameters
1. Raw Materials Specifications2. Packaging Materials Specifications3. Intermediate Product Specifications4. Bulk Product Specifications5. Finished Product Specifications
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1. Raw materials (API / excipients) specifications –- Material name- Product code- Any alternative name or proprietary name- Physical description- Respective to reference limits for:
- Identity- Purity- Physical- Chemical characteristics
- Microbiological standards
Specifications
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Microbiological standards
TAMC: Total Aerobic Microbial CountTYMC: Total Combined Yeasts/MoldsCFU: colony-forming unit
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2. Packaging materials specifications – direct contact / no contact with theproduct
Specifications
Label Physical Specifications
• Dimensions and color scheme• Quality specifications
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2. Packaging materials specifications – direct contact / no contact with theproduct
Specifications
Label Printed Information
• Product name• Trade mark• Active ingredient(s)• Strength • Quantity • Storage condition• Batch number• Manufacturing and expiry date• Price
• Manufacturing license number• Company name and address
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2. Packaging materials specifications – direct contact / no contact with theproduct
Specifications
Carton Physical Specifications
• Dimensions and color scheme• Quality specifications
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2. Packaging materials specifications – direct contact / no contact with theproduct
Specifications
Carton Printed Information
• Product name• Trade mark• Active ingredient(s)• Strength • Quantity • Storage condition• Batch number• Manufacturing and expiry date• Price
• Manufacturing license number• Company name and address• Dosage• Major warning• Other regulatory requirements
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2. Packaging materials specifications – direct contact / no contact with theproduct
Specifications
Insert / Leaflet Physical Specifications
• Size and folds
Printed Information
• Special warning• All details as required by the local authority
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2. Packaging materials specifications – direct contact / no contact with theproduct
Specifications
Measuring spoon Printed Information
• Material quality specification• dimension• fluid capacity• markings
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2. Packaging materials specifications – direct contact / no contact with theproduct
Specifications
Immediate container Printed Information
• Material specifications• Size• Shape• drawing• control limits• Molding
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2. Packaging materials specifications – direct contact / no contact with theproduct
Specifications
Closure Printed Information
• Material specifications• Size• drawing
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Specifications
2. Immediate product specifications – important for IPQC
Intermediate stage Specifications
Granulation and drying
• Homogeneity of the content• Moisture content
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Specifications
2. Immediate product specifications – important for IPQC
Intermediate stage Specifications
Tablet core for coated tablet • Shape• Size • Appearance• Hardness• Uniformity of weight • Dose content
• Dissolution / Disintegration • Moisture content • Abrasion resistance
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Specifications
3. Bulk product specifications – important for finished productquality
• In-house specifications
• Release Specifications
• Registration Specifications
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1. Registration specifications – the specifications that are registered fora product with the regulatory authority.
For example, lower limit and upper limit of API, expiry date, MRP etc.
Specifications
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2. Release specifications – the specifications that a product mustsatisfy before it can be released to the market.
- Should be tighter than the registration specification
- To save the product failing in the market
- To maintain the potency of product during the shelf-life
Specifications
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3. In-house specifications –• Tighter limit than the release specification• An advance alarm to the production department about necessary
corrective measures• Provides an extra protection to the company for marginal analytical
error.• Action can be taken before a batch falls outside the Release
Specifications (i.e. before rejection).
Specifications
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Specifications
Specifications for Paracetamol
In-house limit Release limit Registration limit
API490 – 510 mg/tablet
480 – 525 mg/tablet
475 – 525 mg/tablet
Disintegration Not more than 7
minutesNot more than 10
minutesNot more than 15
minutes
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Specifications
4. Finished product specifications –
Bulk product specification + Packaging specification
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Procedures
• All written instructions of manufacturing, testing or release of aproduct
• Describes the way in which things should be done• Easy for the operators to understand.
• Any changes in the procedures should be duly authorized
• Standard Operating Procedures (SOP) and the ManufacturingInstructions (MI)
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Personnel and Training
People Training
Learning
Assessment
Application
Monitoring
Components
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Personnel and Training
A balanced team for a pharmaceutical operation includes graduatesfrom all disciplines, such as:
- Biochemistry- Chemistry- Engineering- Microbiology- Pharmacy etc.
Components – people
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Personnel and Training
Training – purposes
Training and personnel development are inseparable. Carefullyconducted training program will ensure:
- Better understanding of the people/process/equipment- Uniformity and consistency in manufacturing- Higher quality attainment- Increased productivity- Better perfection in the employees skill.- Faster response
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Training – included topicsTraining program designed for pharmaceutical industries must cover allimportant aspects of its functions:
• Direct effect of medicine on people’s health• Key manufacturing activities• Importance of personnel health and hygiene• Importance of safety precautions• Importance of cleanliness• Need for effective work system
Personnel and Training
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• Importance of manufacturing and testing procedures• Problem of Faulty / Rejected batches• Role of Production, QA/QC and Engineering• Importance and the principle of GMP, validation, productivity
and profitability• How the non-compliance with standards and procedures will
affect patients/consumers, company and employee?
Personnel and Training
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Personnel and Training
Training – modes
• Formal lecture• Symposium• Discussion groups• Workshop
• Must cover employees of all sections• Designed for various levels• Definite objectives
Training records of each staff
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Personnel and Training
Ears Eyes EarsEyes
EarsEyesDiscussion
EarsEyesDiscussionApplication
+ + + + + + + + + + + + + + +
Various training aids for communication
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Personnel and Training
• When information is received through eyes the retention is betterthan ears.
• Discussion and exchange of views generate thinking and itsapplication at the work place makes even better impact onretaining the information by fixing it more firmly in the minds.
Various training aids for communication
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Personnel and Training
• Audiovisual systems like slides/tape presentation and video recordedprogram, are better rather than a simple class-room type lectures.
• Programmed question and answer training aids are also very valuable.
• Combining active learning methods will retain much moreinformation.
Various training aids for communication
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Thank you
Mohammad Ahad A Khan, PhDAssistant Professor, Department of Pharmaceutical SciencesNorth South University, Bangladesh Room: SAC 1013email: [email protected]: +880 17 0386 4707