First step of document to a generic drug development department – SOP for a generic development department
A policy document or SOP for a generic drug development department is an essential requirement to harmonize and standardize the process of documentation at research and development centre who does work to develop new formulations and the formulation would eventually go to the GMP facility.
Not having set of standard development procedures for developing generic drugs may end-up with random non-reproducible process. SOPs are efficient and valuable instructional and working tools for consistant results.
The people working in the pharmaceutical companies, including conducting drug development, must have understandable procedures. The SOP aims to summarize the various regulations and guidelines, which are open to interpretation, into clear and concise sets of instructions.
Basically, generic development can be refined into standard development procedures which any development scientist could implement and use.
The procedures could be paper-based or in electronic form and approved by QA.
Standard Operating Procedures should meet the following primary and operational requirements and, where possible:
• SOP Index
• SOP numbering system
• Format for approval
• Quick ad easy distribution
• Periodic revision
The SOP index is a list of procedure titles and reference numbers. Ideally, the SOP number has three components: department code, serial number, and version number.
Do’s and Don’ts for Development SOP for a generic drug development department
Do – Each SOP has a unique identification number and title.
Do – Ensure all available procedures should be current and within the validity period
Do – Write brief and to-the-point so that they can be read and understood quickly.
Do – Use forms or checklists for extra information and attached to the SOP.
Don’t – Write an SOP that cannot be followed by doers.
Don’t – Write long SOPs. (SOP should be 1 to 5 pages)
Don’t – Prepare SOPs only to comply with requiremnt of regulations. Use it for day-today operation and to train applicable staff.
Don’t – Let SOPs to become stagnant documents. Instead, periodically review and amend on need bases.
What should Drug development SOPs consist of?
The SOP should be in line with drug development unit expectations and efficient enough to produce drug products on time and the first time right. In addition, it should meet all the current requirements required by regulations, organizations goal, and be optimized to meet a multi regulatory environment.
SOP should be inline with current regulatory requirements where, scientists’ represent the most suitable and scintific work through ‘state-of-the-art’ techniques.
A scientist must maintain record of every element of the product development. That includes advances and the failures of the experimental batches.
The adequate documentation process demonstrates that an organization is following a key rule of good practice that the experiments are fully documented and described so that they can be replicated at any given point of time.
The development SOP is structured document that act as road map for scientists to complete the product development work, end to end.
Check List for Ideal SOPs for generic development department and GMP facilities
1. Should have SOP index for all the Research and Development Center and GMP facility SOPs?
2. Should have SOP for Preparation of SOP and that SOP also should have part of SOP index.
3. Maintenence of SOPs as per Index and Specify if any SOP is discontinued in the Index.
4. SOPs should be available in commonly used language or in vernacular language for better understanding and efficient use.
5. All the SOPs should have unique numbering system. NUmbering system should be easy to read and understnd and should provide meanigful information.
6. Each SOPs should be available in approved form, signed by authorized indivisual as guided by SOP for SOP. Sign should have date along with it.
7. Available SOPs with all the departments and functions should be current and in effective form. Old, previous version of SOP should be removed immediately on making new SOP effective.
8. Applicable staff for respactive SOP must be trained before it gets effective?
9. After appoval of SOP, sufficient time should be provided to impart training? Mnadatory period, for example 30 business days can be defined between SOP approval and SOP made efective. This mandatory period will force responsible staff to proactively approve the SOP and sufficient time for training.
10. SOPs should be to the point and easy to follow for consistant output.
11. Responsibility of applicable role should be clearly defined in the SOP and it should not have any ambiguity.
12. Procedure should be prepared to provide formulation specifiec guidance to provide clear path to the scinetists for consistant outcome.
13. The procedure should guide end to end path to complete development work.
14. SOPs should beperiodically enhanced to identify any gap from current guidance and regulatory requirement.