Schedule M Browser
Browse the full text of the Revised Schedule M (2025). We've organized the gazette notification into an indexed, searchable structure complete with plain English explanations for complex requirements.
Part V
Documentation
Documentation System
An effective documentation system is essential for Good Manufacturing Practice. Written procedures shall ensure proper documentation covering specifications, manufacturing formulae, processing and packaging instructions, procedures and records for each batch. Clearly written documents prevent errors from spoken communication and permit tracing of batch history. Documents shall be approved, signed and dated by the authorized person.
AI Explanation
Good documentation is the backbone of GMP. Everything must be written down — formulas, procedures, records. This prevents verbal miscommunication and lets you trace any batch's complete history. Someone authorized must approve and sign every document.
Batch Manufacturing Record (BMR)
A Batch Manufacturing Record shall be kept for each batch processed. It shall be based on the relevant parts of the currently approved Master Formula and processing instructions. The method of preparation of the BMR shall include steps to ensure it is an accurate copy of the approved document. The BMR shall contain: product name and batch number, dates and times of commencement and completion, identification of major equipment used, record of in-process controls, any deviation from the approved procedure with written justification.
AI Explanation
Every batch needs its own manufacturing record based on the master formula. It must include: product name, batch number, start/end times, which equipment was used, in-process checks, and any deviations with explanations.
Standard Operating Procedures (SOPs)
Standard Operating Procedures shall be maintained for all critical operations including but not limited to: equipment cleaning and assembly, environmental monitoring, sampling and testing, handling of deviations and complaints, product recalls, change control, and stability monitoring. SOPs shall be reviewed at least once every two years and updated as necessary. All SOPs shall be readily available at the point of use.
AI Explanation
You need SOPs for every important activity — cleaning, testing, handling problems, recalls, and more. Review all SOPs at least every 2 years. Make sure workers can easily access the SOPs where they need them.