Packaging, Labeling & Storage

Question 1

Describe Packaging, Labeling and Storage

Answer 1

• Containers and materials
• Packaging and labeling
• Storage and transportation
  
  • Cold: not exceeding 8C
  • Cool: 8~15C
  • Room temperature: 20~25C
  • Warm: 30~40 C
  • Excessive Heat: >40C

Question 2

Describe the Container materials of Glass.

Answer 2

• Advantage of glass (over plastics)
  
  • Superior clarity, facilitating inspection;
  • Less frequently interacts with preparations (e.g. drug adsorption)
• Glass (page 82 Table 3.3):
  
  • Class I: highly (chemically) resistant borosilicate glass
  • Class II: treated soda lime glass
  • Class III: soda lime glass (more leaching of alkali from glass into solution)
  • NP: General Purpose soda lime glass (not for parenterals)

Question 3

Describe the Container Materials:

Plastics

Answer 3

• Plastics
  
  • Polyvinylchloride (PVC): flexible
  • Polyolefin (polyethylene PE)
• Advantage of plastic (over glasses)
  
  • Durability
  • Easier storage
  • Easier disposal
  • Reduced weight
  • Improved safety
  • Various choices and characters
• Disadvantages (next slide):

Question 4

Describe the disadvantages of Plastic Materials

Answer 4

• Permeability to oxygen and vapor
• Leaching of the constituents of the container
  
  • Plasticizers, stabilizers, antioxidants, colorants,…
• Sorption, Absorption of drugs
• Transmission of the light
• Alteration of the container
  
  • Deformations, softening, hardening, aging
• Not all the clear plastics are the same

Question 5

What is GMP?

Answer 5

• Current Good Manufacturing Practice (cGMP)
  
  • Promulgated in 1963 under the provisions of Kefauver-Harris Drug Amendments
  • Regulations established by FDA to ensure the minimum standards are met for drug product quality in the United States
  • Apply to both domestic and foreign suppliers and manufactures
  • Establish requirements for ALL aspects of pharmaceutical manufacture
  • FDA inspects the facilities and production records
• Noncompliance with cGMP can lead to regulatory actions by the FDA
  
  • Delay NDA approvals
  • Remove products from market, withdraw approvals…

Question 6

What is Quality Assurance (QA)

Answer 6

Quality Assurance (QA) : Provision to all concerned the evidence needed to establish confidence that the activities relating to quality are being performed adequately:

• Training of personnel
• Monitoring the manufacturing process and environment
• Process documentation and archive
• Validation: Documented evidence that a system does what is purports to do
  
  • Equipment, software, instrumentation
  • Process validation: Manufacturing process; QC testing

Question 7

What is Quality Control?

Answer 7

Quality Control (QC ): The regulatory process through which industry measures actual quality performance, compares it with standards, and acts on the difference, for examples:

• Purity and strength
• Sterility testing
• Pyrogen testing
• Clarity testing

Question 8

What is involved in Quality Management?

Answer 8

Qualilty Assurance and Quality Control

Question 9

Describe what is involved in Good Compounding Practice

Answer 9

Pharmaceutical Manufacturing & Compounding

• _Manufacture _ large scale production for distribution and sale
• Entirely regulated by FDA
• Compounding: professional preparation of prescriptions for specific patients (—— FDA Modernization Act: 1997)
  
  • For products that are not commercially available
  • A heritage of Pharmacy, regulated by State Boards of Pharmacy

NABP (National Association of Boards of Pharmacy)

• Good Compounding Practices applicable to State-Licensed Pharmacists (page 79)
• Compounding: 1) bases on Practitioner/patient/pharmacist relationship; 2) limited amounts

Question 10

What are the USP Standards on Compounding?

Answer 10

Enforceable USP General Chapters:

• <795> Pharmaceutical Compounding – nonsterile Preparation
• <797> Pharmaceutical Compounding – sterile preparation

Informational USP General Chapters:

• <1075> Good Compounding Practice
• <1143> Quality Assurance in Pharmaceutical Compounding
• <1160> Pharmaceutical Calculation in Prescription Compounding

Question 11

What are the USP General Chapter 795?

Answer 11

Pharmaceutical Compounding – nonsterile Preparation

• Compounding environment
• Stability of compounded preparations
• Ingredient selection and calculations
• Checklist for acceptable strength, quality and purity
• Compounded preparations
• Compounding process
• Compounding records and documents
• Patient Counseling

Question 12

What is the USP General Chapter 797?

Answer 12

Pharmaceutical Compounding-sterile preparation

• Special requirements of
• Microbial Contamination Risk Level
• Responsibility of Compounding Personnel
• Personnel Training and Evaluation in Aseptic manipulation Skills
• Verification of Compounding Accuracy & Sterility
• Environmental Quality and Control
• Storage and Beyond-use Dating