Lecture 9 Flashcards

Manufacturing v.s. Compounding Processes

1
Q

Manufacturing Basics

A
  • Produce large scales of drugs and drug products for distribution and sale
  • Quality Assurance (QA) & Quality Control (QC) involved
  • Follow Good Manufacturing Practices (CRF Title 21)
  • Inspected by FDA
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2
Q

Compounding Basics

A
  • Prepare prescriptions for specific patients and in anticipation of drug orders from routine
  • Can also be for teaching and research
  • Follow Good Compounding Practices (USP <795> and <797>)
  • Inspected by corresponding state Board of Pharmacy
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3
Q

Need for Quality

A
  • shared goal by those that inspect the respective drug creators
  • Need to contain labeled amount of medications and releases the drugs as designed (Batch-to-batch consistency and stability)
  • Changes to approved products are strictly controlled by regulatory authorities
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4
Q

Regulated Changes to Approved Drug (4)

A
  1. Formulation
  2. Manufacturing process (drug & drug products)
  3. Packaging
  4. Labeling
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5
Q

Manufacturing - Facilities

A
  • Design and construction of building
  • Lighting
  • Ventilation/air filtration
  • Plumbing
  • Sewage/sanitation
  • Washing & toileting facilities
  • Maintenance facilities
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6
Q

Compounding - Facilities

A

Separate areas for sterile and non-sterile compounding that are:

  • Good state of repair
  • Clean & sanitary
  • Surfaces cleaned before and after compounding

Adequate lighting & ventilation

Adequate washing facilities (other than restroom and near the compounding room)

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7
Q

Manufacturing - Equipment

A

Design & construction:

  • Materials used to make equipment
  • Substances for operation of equipment

Cleaning & Maintenance

  • Equipment and utensils
  • Written procedures
  • Verification of cleaning
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8
Q

Compounding - Equipment

A

Must be cleaned and maintained

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9
Q

Manufacturing - Personnel

A

QC/QA (QA is upper level than QC)

Defined responsibilities of QC:

  • Inspect rooms/certification of balances
  • Correct materials and sufficient qualities
  • Authority to approve or reject batches

Personnel qualifications & responsibilities for positions:

  • Properly trained and attired
  • “Adequate number of qualified personnel”
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10
Q

Compounding - Personnel

A

Pharmacist:

  • inspects & approves products
  • Reviews records
  • Responsible for maintenance
  • Properly trained
  • Properly attired
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11
Q

Manufacturing - Ingredients

A
  • Quality ingredients - USP-NF and other specifications
  • Proper storage
  • Receipt of all ingredients
  • Tests to verify that ingredients are what they’re supposed to be
  • Approving ingredients for use
  • Rejecting ingredients that do not meet specifications
  • Retesting approved ingredients
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12
Q

Compounding - Ingredients

A

Quality ingredients - USP-NF

Proper storage:

  • USP-NF or manufacturer instructions
  • Temperature is monitored in all places drugs are stored
  • Flammable and hazardous products
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13
Q

Manufacturing - Required Testing of Solids

A

After production criteria to release batch:

  • Appearance
  • Identification
  • Potency (content testing)
  • Content uniformity
  • Dissolution
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14
Q

Compounding - Required Testing for Solids

A
  • Identification
  • Physical properties - particle size & morphology
  • Potency
  • Impurities
  • Other: moisture content and residual solvents
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15
Q

Manufacturing - Procedures

A
  • Written procedures
  • Documentation of all deviations
  • Charge-in of components
  • Equipment identification
  • Time limitations on production
  • Control of microbiological contamination
  • In-process sampling
  • Reprocessing
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16
Q

Compounding - Procedures

A

Formulation record:
-Written procedures on file as “receipts” for all previously compounded products with sufficient details to duplicate product

Compounding record:
-Record of prescriptions compounded in the pharmacy

17
Q

Manufacturing - Final Check Process

A
  • Yield
  • Physical characteristics
  • Drug Release Testing
  • Stability Testing
  • Packaged & labeled - issuance of labels, tampering-resistant packaging of OTCs, expiration dating
18
Q

Compounding - Final Check Process

A
  • Yield
  • Physical characteristics
  • Labeling : contents verified with order, legal requirements, storage and administration directions
  • Packaged
  • Documentation
  • Patient Counseling
19
Q

GMP Additional Requirements (3)

A
  1. Retain samples
  2. Warehouse and distribution procedures
  3. Scale-up and Post Approval Changes (SUPAC)
20
Q

Retention of Samples

A
  • 2x quantity needed for testing

- Keep for 1 year post expiration

21
Q

SUPAC

A
  • Scale-up involves changes in equipment and processes
  • Most changes require FDA approval before implementing
  • “Reportable” changes - adding sieving step, change in mixing times, addition of in-process test
22
Q

GCP Labeling

A
  • Generic or chemical name of active ingredients - NOT brand name
  • Strength & quantity included
  • Pharmacy lot number
  • BUD (beyond use date)
  • Inactive ingredients
  • Special storage requirements
23
Q

Manufacturing - Records (8)

A
  1. Batch product records - procedures and ingredients used each time
  2. Equipment - cleaning, use, maintenance
  3. Distribution records
  4. Complaint records
  5. Returned/salvaged drug products
  6. Environmental monitoring for each production run
  7. Personnel training - GMP training
  8. Inventory - drugs, excipients, labels & packaging materials, etc.
24
Q

Compounding - Records (4)

A
  1. Formulation record - recipes of compounded products with sufficient detail to duplicate
  2. Compounding record - record of scripts made and specific product compounded
  3. Equipment maintenance record - documents maintenance and performance checks on all equipment used
  4. Ingredient record - chemical inventory including certificates of purity/analysis and their MSDS