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Pharmaceutical Good Manufacturing Practices (GMP) thrive on Good Documentation Practices (GDP). It is one of the most important requirements of the Quality Management System. It is popularly said that “Anything which is not documented, is not done”. Documentation is the key to GMP compliance and ensures traceability of various activities viz. development, purchase, storage, dispensing, manufacturing, testing, quality management documents, market complaint.
A well written document clearly highlights the responsibilities, accountabilities, scopes, methods, procedures, glossary (if any), abbreviations, change history, annexures, formats etc. In a GMP environment a firm creates various types of documents namely Policies, Manuals, Standard Operating Procedures (SOPs), Standard Testing Procedures (STPs), Validation Master Plan (VMP), Site Master File (SMF), Drug Master File (DMF), Batch Manufacturing Records (BMR), Batch Packing Records (BPR), Validation protocols and reports, records etc. Apart of these internal documents, a firm should have and shall always refer to National Act, International guidelines and regulatory notifications.
Documentation Hierarchy:
Documentation hierarchy defines the structure of the documents that should be processed in an order or be referred to, while performing day to day activities.
There is no set pattern or sequence in which a documentation shall be arranged in a hierarchy. However, a widely accepted documentation hierarchy is given below:
At the apex of the pyramid lies National Act, International guidelines and regulatory notifications. The requirements as mentioned in the national act are considered as ‘law of land’ i.e. these are the requirements which any firm must fulfil to operate in the respective country. International guidelines and regulatory notifications provide the minimum set of requirements that a firm must comply to be in a state of compliance with the expectations of the respective regulatory agencies. As these documents are the ultimate set of requirements that a firm must follow, hence, the same has been given the utmost importance.
Next in the hierarchy are manuals which includes quality manual, safety manual etc. These documents provide the management objectives related to quality, safety and compliance. It provides guiding principles that everyone associated with the company must align themselves to meet the quality and safety objectives set by the management.
Followed by manuals, there lies Quality Policy, EHS Policy, HR policy etc. It describes the intention of the company in conducting its business. The policies are derivatives of their respective manuals. The policies provide brief statement that aligns with the organization’s purpose and strategic direction, provides a framework for quality and safety objectives, and includes a commitment to meet applicable statutory or regulatory requirements.
Next to follow are the documents like Standard Operating Procedures (SOPs), Standard Testing Procedures (STPs), Validation Master Plan (VMP), Site Master File (SMF), Drug Master File (DMF) etc. which provides detailed requirements to be followed by the individuals working in the firm to remain in the state of compliance. These documents provide step by step procedures to be carried out so that the firm complies with the requirements of GMP and other regulatory guidelines.
Penultimate one consists of Batch Manufacturing Records (BMR), Batch Packing Records (BPR), Validation protocols and reports. These consists of step by step instructions to perform each activity. BMR and BPR provides step wise instructions to be carried out for manufacturing product meeting consistent quality parameters, Validation protocols provides instructions to carry out validations of processes, qualifications of equipment etc.
At the last lies environmental records, test records, raw data sheets, data recording sheets etc. which helps to record the data generated during carrying out of various processes.
