Design of Materials and Product Specifications for Pharmaceutical Dosage Forms
摘要
The supply of standard-quality pharmaceutical products to consumers is the prime accountability of manufacturers. To sustain this, pharmaceutical companies must comply with all explicit norms and guidelines, producing conventional to novel drug delivery systems to make them marketable. Reproducibility is the mandatory criterion in the successful fabrication of dosage forms; therefore, many new inputs are being carried out, including a quality-by-design (QbD) approach from the starting material up to the FP. The ICH Q6A guideline explains specifications in terms of analytical procedures, various tests, references and suitable acceptance criteria, and materials and DP must conform to these specifications. Three types of specifications have been set for various developmental stages of a dosage form: in-process specification, release specification and shelf life specification. In the ICH Q8 guideline, QbD is well explained. ICH Q6A, ICH Q6B guidelines and QbD help design the FP within specifications. Identification of critical quality attributes (CQAs), quality target product profile (QTPP) and necessary process parameters (CPPs) are required for QbD implementation. It works on identifying risks, executing the design of experiments (DOE), analysing risks and, finally, defining the design space. A control approach is used throughout the process to ensure that goods have a constant and predetermined quality. Different guidelines of regulatory authorities also must be followed by pharmaceutical companies to get their products approved for marketing.