This trend is disappointing. Numerous webinars, seminars, and workshops designed to train personnel in the art of writing and following SOPs are presented every year. A myriad of articles, books, and manuals discuss the who, what, when, where, and how of SOPs. There are numerous companies, consultants, and experts that a company can hire to write, review, and critique these procedures as well.
Every company in the pharmaceutical industry has training programs to ensure that employees are provided with—and understand—current SOPs. When considering the various tools available to the industry regarding such procedures, it's unclear why industry still has trouble following its own instructions.One reason may be the need for customized SOPs, which are often required by clients of contract manufacturing organizations (CMOs). Contract organizations typically write SOPs to accommodate diverse opinions on how a particular process should be implemented in order to guarantee compliance. These SOPs are presented to prospective customers as a part of due-diligence activities. Occasionally, a customer will insist on supplying the CMO with its own version of the SOP activity and demand that the CMO implement the procedure when manufacturing its product. This approach can be disruptive to the CMO for several reasons. For starters, the CMO's employees need to be trained on two procedures for one activity, and they must understand when and why, and in what situations they should use one SOP over the other.
Consider the following scenario: CMO A has an established SOP for performing visual inspections on final filled vials before packaging them. The SOP indicates the predicted reject rate associated with various vial defects that might occur as a result of the manufacturing process. Examples of some of the indicated defects are cracked vials, misplaced stoppers, poor crimps, and so forth. Each defect has an established reject rate based on production capabilities. Company A, a new client, has just qualified CMO A as an alternate supplier for their life-saving medicine because its primary supplier is unable to keep up with market demand. Company A would like CMO A to use its inspection SOP for visual inspection purposes. There are major differences between the two SOPs, including the defect categories, the established reject rates for defect categories, and the inspection report forms. Company A's SOP has more defect categories, and the reject rates are tighter than CMO A's SOP, which prompts the use of the different inspection report form.
As a further example, an experienced, trained employee at the CMO is performing the vial inspection for Company A's product and forgets that there is a custom SOP for this process step. The employee completes the inspection and turns in the results to the manufacturing quality assurance (MQA), which detects the error and initiates an investigation. The lot in question must be reinspected using Company A's SOP, and the appropriate acceptable quality levels (AQLs) must be applied to the product lot in question. This reinspection delays the release of the product by several weeks and can cause a stock-out situation in the field.
Another problem CMOs face when using customized SOPs is how to handle conflicting SOPs. Consider the following scenario: CMO B has just been selected by Company B to manufacture its product.