First, it is important to know what the “ills” are. These (“ills”) are not usually specific but described by some (inspectors/investigators) from regulatory authorities, in particular, FDA, with observations and statements following facility inspections.
These facility inspections are conducted under the requirements of Good Manufacturing Practices or GMP, which are usually part of the country’s laws and regulations, giving the practices “authenticity” and enforcement ability. The GMP requirements and implementation are based on the fundamental assumption that GMP requirements are enforced so that the end products from manufacturing are of quality. For example, per FDA, “FDA ensures the quality of drug products by carefully monitoring drug manufacturers’ compliance with its Current Good Manufacturing Practice (CGMP) regulations” [Link].
A quick literature survey provides examples of some descriptions of observed deficiencies (often also known as “observations”) of compliance requirements. These deficiencies could fall into one of the nine categories such as organization and personnel; buildings and facilities; equipment; control of components and drug product containers and closures; production and process controls; packaging and labeling control; holding and distribution; laboratory controls; records and reports [Link].
These deficiencies or observations are usually descriptive or narrative, not objectively measurable or quantifiable. Therefore, these can be considered subjective, based on the individual investigator’s personal judgment or inclination, as noted by the FDA, e.g., “During an inspection, ORA investigators may observe conditions they deem to be objectionable.
These observations are listed on an FDA Form 483 when, in an investigator’s judgment, the observed conditions or practices indicate that an FDA-regulated product may be in violation of FDA’s requirements [Link].
Once such observations become public, people (often experts/consultants external as well as internal to agencies) blow these out of proportion arguably for their own personal and business advantages and benefits [e.g., see here]. These (“observations”) then promoted as “ills” of the manufacturing and the industry.
In short, the opinions expressed, formally or informally, by the investigators/inspectors mostly about the operation are considered as “ills” of the industry and manufacturing.
It is important to note that, as per GMP requirements described above, inspections must establish or relate to the ability to manufacture quality products. However, as stated above, most noted deficiencies are related to manufacturing and its operation – not the product quality. For example, the outcome of an inspection or warning letter is usually concluded as follows: “Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 USC 351(a)(2)(B)” [link, link].
The question is: where is the evidence of manufacturing of substandard quality (or adulterated) products?
The product’s quality can only be established by testing it, which is mostly neither part of the inspections nor “observations” claims. It is like saying that as the staff was not found adequately cleaned and dressed (in the investigator’s view), staff would be considered to lack intelligence and competence for the job.
For the validity of such a statement or conclusion, it must be based on evaluating and establishing their competence and intelligence and must be established independently. However, experts/consultants would conclude and promote inspections/observations as product deficiencies or inability to manufacture “quality” products – these are simply false assumptions and conclusions because observations are not linked or validated against the deficiencies of the product quality.
Therefore, blaming the manufacturing or industry for poor manufacturing quality products would generally be inaccurate. Instead, it is the practice of the current investigations or inspections which needs to be reassessed. To make “observations” or inspections, logical and scientifically valid agencies should define the quality of the products with a measurable parameter.
Samples should be collected at appropriate checkpoints and evaluated against (strictest) pre-set standards and specifications for the quality of products. On the other hand, manufacturers and affiliated contract facilities should seek help in addressing and defending the current irrelevant conclusions drawn from the facilities’ assessments and removing the weaknesses of the regulatory (GMP) requirements and practices worldwide.
