Quality management systems part 1 INDUSTRIAL PHARMACY ll

 Quality management systems part 1

INDUSTRIAL PHARMACY ll

BP702TT

B.PHARMA SEMESTER 7

jsmasipharmacy.blogspot.com

syllabus

Quality management & Certifications: Concept of Quality, Total Quality Management, Quality by Design (QbD), Six Sigma concept, Out of Specifications (OOS), Change control, Introduction to ISO 9000 series of quality systems standards, ISO 14000, NABL, GLP

1. Introduction

Quality Management System (QMS) is an important aspect for the pharmaceutical industry for maintaining the quality and safety for their products and services.

 QMS relies on the regulations and guidelines to maintain the effective quality in pharmaceutical industries. 

According to US FDA, the international harmonized guidance(ICH) is intended to assist pharmaceutical manufacturers by describing a model for an effective quality management system for the pharmaceutical industry. 

2. Concept of Quality

2.1 Quality Assurance (QA) According to WHO, “Quality assurance” is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use.

2.2 Quality Control (QC) is that part of GMP concerned with sampling, specification, testing, documentation and release procedures which ensure that the necessary and relevant tests are performed and the product is released for use only after ascertaining its quality.

2.3 Scope of Pharmaceutical QMS

Pharmaceutical Development.
Technology Transfer.
Commercial Manufacturing.

• Acquisition and control of materials.
•  Provision of facilities, utilities and equipment.
•  Production (including packaging and labeling).
•  Quality control and assurance

2.4 ICH Guidelines is intended for bringing together the regulatory authorities and pharmaceutical industries together for the discussion of the scientific and technical aspects of drug registration.

It is divided into four categories (QSEM):

• Q: Quality guidelines - It includes stability, impurities testing, GMP.
• S: Safety guidelines - It includes carcinogenicity, genotoxicity, reprotoxicity.
• E: Efficacy guidelines - It includes clinical, pharmacogenomics.
• M: Multidisciplinary guidelines - It includes medical dictionary for regulatory activities, electronic standards, non-clinical safety studies, common technical document (CTD).

Quality Guidelines

Safety Guidelines

Efficacy guidelines

Multidisciplinary Guidelines

3. TOTAL QUALITY MANAGEMENT

the maintenance of the quality of the drugs is so important in pharmaceutical industries because the poor quality of drugs can cause health hazards and economical burden for both the government and patients.

3.1 Definition

As per  ISO, TQM is defined as: “A management approach of an organization centered on quality, based on participation of all its members and aiming at long term benefits to all members of the organization and society”.

key components of TQM:

•  Consumer/Customer focus
•  Involvement of employee
•  Continuous improvement

3.2 major tools used for statistical process control

• Histogram: A histogram is an accurate representation of the distribution of numerical data
• Pareto chart: chart that contains both bars and a line graph, where individual values are represented in descending order by bars, and the cumulative total is represented by the line
• Cause and effect diagram (Fish bone diagram): It helps to identify the possible causes of a specific problem or quality characteristic
• Defect concentration diagram
• Control chart
• Scatter diagram
• Check sheet: The check sheet is a form or document used to collect data in real time at the location where the data is generated

3.3 Advantages

1. Improve in quality and safety of the drugs.

2. Improvement of customer satisfaction.

3. Improvement of reputation of industry.

4. Total involvement of employee with higher moral and responsibilities.

5. Lower economic burden.

4. QUALITY BY DESIGN (QbD)

4.1 Definition

According to US FDA and ICH Q8 (R2) the "QbD is a systematic approach to development

which includes the prior knowledge of product and process understanding based on the

results of studies using design of experiments, use of quality risk management and use of

knowledge management"

4.2 objectives of QbD

• Increasing manufacturing efficiency.
• Increasing the efficiency in product development.
• Enhancement of product quality and performances to meet patients’ needs.
• Increase in process capability.
• Avoidance of regulatory compliances.
• Incorporation of risk management.
• Reduction in production costs and waste.
• Reduction in product variability, defects and rejections.

4.3 outcomes of QbD 

• Maintenance of product quality to meet expected clinical performances.
• Maintenance of product quality by efficient manufacturing and formulation process.

4.4 Elements of QbD

• QTPP (Quality Target Product Profile)
• CQAs (Critical Quality Attributes)
• Determination of CQAs
• Suitable manufacturing process selection.
• Risk assessment
• Defining a control strategy

4.4.1 Quality Target Product Profile (QTPP)

It includes:

1. Dosage forms, route of administration, delivery systems.

2. Strength of doses.

3. Container closure system.

4. Pharmacokinetic properties.

5. Drug product quality criteria.

4.4.2 Critical Quality Attributes (CQA)

CQA is related with drug substance, excipients, intermediates (in-process materials) and

drug product. CQA is a physical, chemical, biological or microbiological property to ensure the desired product quality.

4.4.3 Risk Assessment: 

• CMAs (Critical Material Attributes) 
•  CPPs (Critical Process Parameters)

Risk assessment, is used in QRM (Quality Risk Management, mentioned in ICH Q9). This assessment identifies materials attributes and process parameters effectively that have an effect on product CQAs. Based on prior knowledge and initial experimental data, risk assessment method helps to identify and rank different parameters like process, equipments and input materials with potential that have an impact on product quality.

4.4.4 Control Strategy

The pharmaceutical product should be produced with required quality in consistent

fashion and the control strategy ensures this. It includes the following elements

• Control of input material attributes viz., drug substance, excipients, packagingmaterials, 
• Product specifications.
• Controls of unit operations that have a role to maintain the product quality.(granulation, drying, degradation, particle size distribution, etc.)
•  In-process testing.
• Finished product testing.
•  Testing of products at every stage at regular intervals (Monitoring program)

5. SIX SIGMA CONCEPTS

 principle for the process improvement. Six sigma represents the quality level which is implemented for reducing the operational costs in pharmaceutical industry and serving the best customer satisfaction and services. 

Six sigma is symbolized as “6σ”. Six sigma is a statistical measurement of product variables. This concept helps to achieve stable and predictable process results with continuous quality improvement

5.1 Aim of Six Sigma Concept

1. Process improvement

2. Improved methodology

3. Improved quality

4. Customer satisfaction

5. Reduction in process variation

6. Reduction in costs

7. Fewer defects to achieve the goal

8. Continuous quality improvement

Six Sigma Process: DMAIC

PART 2 (CLICK HERE)