Critical to Pharma: How to heal Manufacturing and Product Development pains

Product Development:

Quality by Design

Ensure quality ingredients and effective drugs

One of the goals of quality by design is to identify, explain, and manage all sources of variability affecting a process, ensuring products consistently meet predefined characteristics and supporting process innovations like:

research, testing, improvement, and validation of active ingredients
dosage forms
effective drug combinations
expansion of the use of existing active ingredients
improved or new manufacturing processes

Relevant Minitab tools include:

House of Quality
CTs
FMEA
Equivalence tests
Monte Carlo Simulation
Design of Experiments (DOE)

Product Manufacturing:

Continued Process Verification

Control, validate, and maintain standards

Good Manufacturing Practice (GMP) describes the minimum standard that a manufacturer must meet in their production processes. GMP requires that drugs:

are of consistently high quality
are appropriate for their intended use
meet the requirements for marketing authorization or clinical trial authorization

The following techniques are used in the pharmaceutical industry for Continued Process Verification:

process performance validation
analytical method validation
knowledge of the interaction between measurement error and process stability
measurement imprecision and bias estimation

Relevant Minitab tools include:

Measurement System Analysis (MSA)
Process maps
Value Stream Map (VSM)
Process Capability (Cpk, Ppk)
Pareto chart, Ishikawa diagram
C&E matrix
Control charts
Stability studies
Control plan

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Compliance:

Accurate, Comprehensive Data

Document data integrity and validate software

Data relating to product liability, pharmacovigilance, and accountability is key to securing- and renewing - authorization to release a product.

Businesses must meet FDA and other regulatory agency requirements by validating software according to their intended use. Organizations need to provide:

Supporting quality process documentation
Validation tests
User requirements and functional specifications
Operational qualification control
Electronic records and signatures

Data integrity is required by Title 21 of the FDA Code of Federal Regulations (CFR21) and the EMA's scientific guidelines. Data should be:

Attributable (ALCOA)
Legible (ALCOA)
Contemporaneously recorded (ALCOA)
Original or a true copy (ALCOA)
Accurate (ALCOA)

Relevant Minitab tools include:

Measurement System Analysis
Attribute Agreement analysis
Process Capability Analysis (Cpk, Ppk)

Case Study

Catalent

Catalent Produces Treatments Faster and Better Using Automated Statistical Process Control.

THE CHALLENGE

Improve production quality and cycle time while complying with new Process Analytical Tools regulations

THE RESULT

Two potential lost batches and £50.000 saved in two weeks

Read the Case Study

Webinar

Shire Pharmaceuticals

Critical Checks for Pharmaceuticals: Is your data reliable enough to identify the root cause of impurities?

When manufacturer Shire Pharmaceuticals identified impurities in rare disease treatments, investigations began: what was the cause, the measurement system or the process?

Without understanding the cause, the impurities risked the release of a product that was not compliant and could affect patient safety.

Watch Now On-Demand

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Validating Your Data Integrity and Process Performance

Pharmaceutical companies, and other organizations in the health sector, must apply rigorous, complex techniques to support process validation, monitoring, and performance evaluation. Learn about three 'critical checks' that will help you accomplish these goals.

How to Use Value Stream Maps in Healthcare

Value Stream Maps (VSM) visualize every step required to complete a process from start to finish, helping the user understand the flow of materials and information. These insights can be used to identify process improvements like reducing waste or increasing speed.

Determining the Shelf Life of Your Pharmaceutical Product

Read this use case to learn how a quality engineer at a pharmaceutical company might conduct a stability study with a fixed batch factor to estimate the shelf life for pills containing a new drug by determining when the pills get to 90% of the intended concentration.