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Pharmaceutical Quality Assurance Notes Free PDF Download – 2021
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L1 – Complaints and Recalls Handling
Complaints is defined as statement that is something wrong or not good enough ,which shows customer dissatisfaction about the company and the product.
L2 – Complaints and Recalls
Complaints is defined as statement that is something wrong or not good enough ,which shows customer dissatisfaction about the company and the product.
L3 – Waste Management
Pharmaceutical waste management is an important part in pharmaceutical industries. Wastes are the unwanted materials which can no longer be used in the manufacturing processes that can eventually turn into hazardous or non hazardous material, to humans/environment. Management of the hazardous wastes is an integral part of pharmaceutical industries. Pharmaceutical wastes are in different forms mainly as strips, expired products, manufacturing wastes etc. It comes from various sectors in the health care system including pharmaceutical developers and manufactures, hospitals, individual physicians and all those who are involved in the health care system.
L4 – Pharmaceutical Documentation
Documentation is any communicable material that is used to describe , explain or instruct regarding some attributes of an object, system or procedure, such as its parts, assembly installation, maintenance and use.
Documentation provides both:
- Information on when, where, who, why, and how to complete tasks.
- Evidence providing that the tasks have been completed as they should be.
L5 – Batch Manufacturing Records
Batch manufacturing records should be prepared for each intermediate and API/formulation and should include complete information relating to the manufacturing and control of each batch.
L6 – Master Formula Record
Master Formula Record (MFR) is a master document for any pharmaceutical product. MFR contains all information about the manufacturing process for the product. MFR is prepared by the research and development team of the company.
L7 – Quality Audits
A systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives
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L8 – Standard Operating Procedure
A standard operating procedure (SOP) is a set of written instructions that document a routine or repetitive activity followed by an organization.
L9 – Records and Distribution
The division and the movement of pharmaceuticals products from the premises of the manufacturer to the end use or to an intermediate point means of various transport methods.
L10 – Analytical Method and Validation
The division and the movement of pharmaceuticals products from the premises of the manufacturer to the end use or to an intermediate point means of various transport methods.
L11 – QA and QC Concepts
- What is Quality?Quality is the ability of your product to be able to satisfy your users
- What is Quality Assurance?
L12 – QA vs QC
Difference between Quality Assurance and Quality Control
L13 – Total Quality Management
- Total Quality Management (TQ, QM or TQM) and Six Sigma (6σ) are sweeping “culture change” efforts to position a company for greater customer satisfaction, profitability and competitiveness.
- TQ may be defined as managing the entire organization so that it excels on all dimensions of products and services that are important to the customer.
- We often think of features when we think of the quality of a product or service; TQ is about conformance quality, not features.
L14 – ICH Guidelines
ICH is a joint initiative involving both regulators and research-based industry representatives of the EU, Japan and the US in scientific and technical discussions of the testing procedures required to assess and ensure the safety, quality and efficacy of medicines.
L15 – ICH Stability Studies
Objective of Stability Testing to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity & light, & enables recommended storage conditions, re-test periods & shelf lives to be established”
L15 – ISO
- International quality certification that defines minimum requirements for a company’s Quality Management System (QMS). A company’s QMS comprises the organization’s policies, procedures and other internal requirements that ensure customer requirements are met with consistency resulting in customer satisfaction. This can be applied to any company
- This international Standard specifies requirements for a quality management system where an organisation needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements
- This aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer
L16 – NABL
- This to provide a means for third-party certification of the competence of laboratories to perform specific type(s) of testing and calibration.
- Laboratory Accreditation provides formal recognition of competent laboratories, thus providing a ready means for customers to find reliable testing and calibration services in order to meet their demands.
- Laboratory Accreditation enhances customer confidence in accepting testing / calibration reports issued by accredited laboratories.
L17 – Quality By Design
- This to provide a means for third-party certification of the competence of laboratories to perform specific type(s) of testing and calibration.
- Laboratory Accreditation provides formal recognition of competent laboratories, thus providing a ready means for customers to find reliable testing and calibration services in order to meet their demands.
- Laboratory Accreditation enhances customer confidence in accepting testing / calibration reports issued by accredited laboratories.
L18 – Calibration And Instruments
Calibration and Validation: Introduction, definition and general principles of calibration, qualification and validation, importance and scope of validation, types of validation, validation master plan. Calibration of pH meter, Qualification of UV-Visible spectrophotometer, General principles of Analytical method Validation
L19 – Validation
- A system must be qualified to operate in a validated process
- Qualify a system and/or equipment
- Validate a process
- Qualification versus validation, e.g. you qualify an autoclave, whereas you validate a sterilization process
L20 – Warehousing
A warehouse is a place used for the storage or accumulation of goods. It may also be defined as an establishment that assumes responsibility for the safe custody of goods. Warehouses enable the businessmen to carry on production throughout the year and to sell their products, whenever there is adequate demand.
L21 – Good Warehouse Practise
A warehouse is a place used for the storage or accumulation of goods. It may also be defined as an establishment that assumes responsibility for the safe custody of goods. Warehouses enable the businessmen to carry on production throughout the year and to sell their products, whenever there is adequate demand.
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