This SOP establishes procedures for documenting deviations from the instructions provided in the Master Manufacturing Record, standard operating procedures, or other specification documents, with the deviations being (a) temporary, i.e. applying to a specific batch or a defined range of batches, and (b) intentional, i.e. approved in advance by quality assurance (QA) and other management. (If the change will apply to all future batches then the MMR or SOP should be updated accordingly; if the change is unintentional or unexpected then see SOP template QA-9010.)
21 CFR 111 does not require companies to implement an SOP for “planned deviations” but rather instructs firms to document “corrective action plans” (21 CFR 111.75(h)(2)(i) and 21 CFR 111.210(h)(5)),“treatments, in process adjustments, reprocessing” (e.g. 21 CFR 111.77(a)), and “deviations or unanticipated occurrences” (e.g. 21 CFR 111.75(b)(2), 21 CFR 111.90).
21 CFR 111 also requires that whenever there is reason to doubt the identity, purity, composition, quality, or suitability of a material, or when there has been any deviation from normal procedures, the quality department must conduct a material review and decide the disposition of the material (e.g. 21 CFR 111.113).
In order to implement these regulatory requirements, companies may use a combination of strategies.
- Instructions for the resolution of common manufacturing issues should be written into the MMR (e.g. “If more than 2% of the capsules exhibit physical defects, perform 100% inspection of the batch as per SOP PD-####”).
- The resolution of unexpected or uncommon issues can be documented using generic SOPs, such as this one for planned deviations or QA-9010 for unplanned deviations. (The author has found it preferable to address planned deviations separately from unplanned, because the steps involved and issues to be considered are somewhat different.)
- Any in-process adjustments that operators are allowed to make during processing of a batch, should be established in the MMR (e.g. “Speed: 20-30 rpm” or “Pin setting: Target =3; allowed range 2 to 4”). Thereafter, any deviation by the operator from the allowed settings should be specially documented and approved by QA, for example as per QA-9010.
- The disposition of materials which are determined to be in some manner nonconforming (e.g. materials which do not meet specifications, or which are contaminated or otherwise unsuitable for use) should be documented, for example as per QA-9030.
- Calibration failures may be investigated and documented as per QA-9020.
Examples of issues which might be documented using this SOP include:
- Adjustments in the amounts of certain ingredients used in a specific batch or range of batches, for example due to a temporary change in the potency of a vitamin ingredient.
- Use of equipment to process the batch which is different from that normally used, and which therefore requires different settings from those normally used.
- Reprocessing or other special treatment of a raw material lot or finished product batch, to bring it into compliance with the applicable specifications.
- Use of a lot of analytical standard beyond its assigned expiration date so long as it retains appropriate characteristics.
The planned deviation report can be used to document planned deviations, such as reprocessing or use of an alternate ingredient, as required by 21 CFR §111.90. The report should be filed with the other records for the batch or lot. In addition, a copy should be filed in the QA department to facilitate periodic review of PDR trends.
The planned deviation report log such can be used to track planned deviation reports. Details about each such deviation should be recorded on a Planned Deviation Report.