Quality Assurance and Control in Pharmaceuticals

Quality Assurance and Control (QA/QC)

• Master Record includes formulations, specifications, manufacturing procedures, quality assurance requirements, and labeling of finished products.
• Drug Articles are substances aimed at diagnosis, treatment, prevention of disease, or altering body structure/function.
• Pharmaceutical Preparations consist of active pharmaceutical ingredients (API) and excipients formulated for human or animal use.

Drug Establishments and Roles

• Drug Importer imports raw materials or finished products for distribution.
• Drug Manufacturing encompasses creation, packaging, labeling, and testing of drug articles.
• Standard Operating Procedures (SOPs) guide essential activities such as batch release, validation, and personnel training.

Documentation and Procedures

• Documentation provides an audit trail and ensures quality control responsibilities are communicated and authorized.
• Quality Control records document test dates, material identification, supplier information, and batch numbers.
• Document control policies include taking obsolete documents from users, archiving them, and marking them appropriately.

Batch Processing Records

• Prepared for each product batch, including details like product name, batch number, formula, and processing steps.
• Must include revision numbers, approval date, preparer's signature, and quality control results.
• Importance of accurate entries, corrections must be initialed and dated without obscuring original data.

Regulatory Bodies

• Global regulatory agencies overseeing pharmaceutical practices include:
  • MHRA (UK)
  • TFDA (Taiwan)
  • HSA (Singapore)
  • DCA (Malaysia)
  • NMPA (China)
  • DCGI (India)
  • TFDA (Thailand)

Good Manufacturing Practices (GMP)

• Guidelines include PIC(s), EU, USA FDA CFRs 210 & 211 & 820, ISO standards, and WHO GMP Guidelines.
• Documents must maintain a complete history from starting materials to finished products.

Unit Operations in Pharmaceutical Manufacturing

• Size Reduction improves processing, pharmacological performance, and transportation efficiency by reducing bulk volume.
• Methods of size reduction include cutting, compressing, impaction, attrition, and combined techniques.

Role of Excipients

• Diluents increase bulk for tablet processing; ideally, they should be inert, non-hygroscopic, and cost-effective. Common diluents include lactose, starch, and microcrystalline cellulose.
• Binders ensure tablet integrity and flow by promoting cohesiveness; can be applied as solutions or powders.
• Lubricants minimize friction during compression processes; an ideal lubricant has low shear strength.

Glidants and Disintegrants

• Glidants enhance flow properties during tablet compression and are added just before compression.
• Disintegrants assist in breaking up tablets in the body, facilitating dissolution through mechanisms like swelling and capillary action.

Objectives of Documentation

• Document activities related to maintenance, storage, quality control, and primary distribution.
• Ensure all records are organized, maintained for an established period, and periodically reviewed for relevance.

Explore the critical aspects of Quality Assurance and Control (QA/QC) in the pharmaceutical industry. This quiz covers master records, drug articles, pharmaceutical preparations, and the roles of drug establishments. Test your knowledge on documentation and procedures essential for maintaining quality standards.