In lay terms, sterilization is understood in a number of ways. We have sterilization in economics, in family planning and in many other fields. When it comes to this term as used by the FDA; there is a specific purpose and definition. For the FDA, sterilization process controls are indispensable for validation. Sterilization is part […]

Q7 guidelines

Q7 guidelines are those guidelines issued by the ICH (International Conference on Harmonization) in relation to Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredient (API). Q7 guidelines are very comprehensive More than 12 years after they were mooted in November 2000; Q7 guidelines continue to be the driving force for API GMP regulations around the […]

Method transfer FDA

A method transfer is the process of qualifying a laboratory regarding its ability to carry out an analytical test procedure. For method transfer, FDA has some regulations that are simple on the face of it, but require many steps and precautions. Not being in compliance with these steps could invite investigation and corrective measures to […]

Master Production Record (MPR)

A Master Production Record (MPR)is one of the several important documents that a manufacturer of finished pharmaceuticals has to maintain and furnish. It is one of the indispensable parts of pharmaceutical good manufacturing practices (GMP’s). FDA’s regulations on Master Production Record (MPR) are found in Code of Federal Regulations (CFR)’s Title 21, Volume 4. The […]

ISO 13485 statistical techniques procedure

Being the global standard for quality management systems in medical devices; ISO 13485 has many controls and checks built in at various stages of the product design and development. One of these is the ISO 13485 statistical techniques procedure. This is a means to ensuring that product characteristics and process capability are measured and checked […]

ISO 13485 purchasing procedure

ISO 13485 has purchasing procedures for suppliers. ISO 13485 purchasing procedure is listed in Section 7.4 and its sub sections. The outstanding feature of this section is that the ISO is not clear about the expected levels of control a supplier has to have in place. It simply states that a documented procedure is required […]

ISO 13485 design and development

ISO 13485 is the blueprint for quality management in medical devices. Design and development being very critical components of a medical device; ISO 13485 design and development is considered a very important section relating to this aspect of a medical device. Being the extant standard; the ISO 13485 standard has superseded a number of previous […]

ISO 13485 customer property

ISO 13485 2003 is the global standard that concerns itself with quality management for medical devices. ISO 13485 has a section on how businesses should deal with customer property. ISO 13485 customer property is covered in ISO 13485: 2003 Section 7.5.4. The aim of ISO 13485 customer propertyis to ensure that the property a customer […]

ICH Q7 guidelines

What is ICH Q7? The ICH Q7 is a globally harmonized GMP guideline for Active Pharmaceutical Ingredients (API). This guideline covers all GMP aspects of manufacturing, quality control and trading of both chemical and biological ingredients of a drug. When did it come into effect? The ICH Q7 was arrived at by the International Conference […]

ICH guidelines for API

ICH guidelines for API are guidelines from the ICH specific to the active pharmaceutical ingredient (API) of the drug. A small note about ICH Q7: The ICH Q7 is a globally harmonized GMP guideline for Active Pharmaceutical Ingredients (API). The scope of this guideline covers all GMP aspects of manufacturing, quality control and trading of […]