A deviation in pharmaceuticals may affect different areas including the materials, machines, and processes. the list of potential areas of deviation are:
List of potential areas of deviations:
- Materials
- Equipment
- Process
- General practices
- documents practices
- test methods
- specifications
Materials:
Raw materials/components, as well as labeling and packaging components, must meet their quality specifications before their usage in manufacturing. yet there will be a situation when unreleased materials might end up in manufacturing, or unapproved labeling components might be used in the labeling/ packaging operation.
in either case, the impact on the quality/compliance status of the product should be reviewed in detail before deciding on its deposition.
Equipment:
the sudden breakdown or malfunction of equipment is an unplanned deviation that could have an adverse impact on the quality.
also, if the equipment is beyond its calibration periods and is used in manufacturing, packaging, or testing of the product, it will compromise its compliance status.
such deviation may not have an apparent effect on the quality, safety, and efficacy of the drug substances but still, have compliance implications.
another deviation could be replacing equipment with similar or comparable equipment in the middle of a manufacturing run. such a change should be documented and justified at the time of occurrence and pre-approved by the QA Team.
Process:
deviation from both process parameters and process conditions could affect the product.
Machine setup, mixing speeds, drying temperature, etc, all should be remains within preset limits. any degression would be a deviation and would require an investigation, especially if the machine setting drifts too far from the validation data.
likewise, process conditions- like temperature, humidity, and the microbial quality of the environment, should be maintained as any change would be considered a deviation and could impact the product quality.
Practices:
if the written procedures are not followed strictly, this will be a deviation as spelled out by regulations. for example, if sampling procedures are not followed, the sample collected will become suspect, and any data obtained from their testing will not be of value to make any quality decisions.
such a deviation requires re-sampling and retesting of materials along with other corrective actions, including the retraining of the employees.
Documentation Practices:
GMPs require that all quality/compliance-related documents be prepared, reviewed, revised, and approved according to a written procedure or SOPs.
Likewise, such documents should be used in a consistent manner; if not it will be a deviation that has to be explained.
documentation practices are a cause for concern throughout the company, and employees should be trained and retrained on this subject.
Test Methods:
Analytical test methods are qualified relative to a given drug substance/ product and set of instruments.
whenever there is a deviation from the approved analytical procedure, it required a detailed investigation and sound scientific justification before the data is accepted for any quality decision.
some deviations are minor, yet these should be documented, while others could lead to a re-evaluation of the analytical method or the instrument used.
sometimes deviation from the approved test method is necessary because of compendial changes, and the written procedure is yet to be reviewed and approved by the organization.
Specifications:
finished product specifications are based on sound scientific data and are a direct result of drug substance/product behavior during the development process.
Raw material and packaging component specifications are either based on the most current pharmacopeia or supplier specifications.
Deviations from approved specifications result in failure and rejection or rework of the materials involve.
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