Pharmaceutical Guidelines
Search

Preparation of a Master Formula Record in Pharmaceutical Manufacturing

Last reviewed 19 Oct 2026 · 7 min read

Contents
  1. What a master formula record does
  2. Regulatory requirements to apply
  3. Separate the master instructions from the batch record
  4. Organize the document around the process
  5. A preparation and review sequence
  6. Batch documentation and retention
  7. Frequently asked questions
  8. Is an MFR the same as a BMR or BPR?
  9. Must every MFR have a process flow chart?
  10. Are one set of MFR headings valid for every market?
  11. Related articles
  12. References

In short: A master formula is the approved set of instructions used to make a product at a defined batch size. EU GMP and U.S. drug CGMP describe related records with different names and specified contents, so prepare the document for the applicable market and product rather than copying a universal template.

What a master formula record does

A master formula record (MFR) is a controlled starting document for planning and recording manufacture. It states the intended formula, equipment and process instructions for a product and batch size. The executed batch manufacturing or processing record is completed for an individual batch and documents what actually happened.

Terminology differs across regulatory systems. India’s revised Schedule M uses “Master Formula Records”; EU GMP calls for an approved written Manufacturing Formula and Processing Instructions; U.S. drug CGMP uses “master production and control records.” “MFR” is common industry shorthand, so check the applicable regulation, product authorisation and site document system when naming the controlled document.

Regulatory requirements to apply

For India, Schedule M Part I, §§17.3.6.1–17.3.6.2 (Drugs Rules, 1945, as substituted by G.S.R. 922(E), 2023) calls for a formally authorised master formula for each product and batch size. Its specified contents include product identity, dosage form, strength and batch size; starting materials and amounts; expected yields; processing location and principal equipment; critical equipment methods; stepwise instructions; in-process controls and limits; relevant storage details; precautions; and permitted hold times for intermediate and in-process materials. Schedule M §17.3.7 addresses packaging instructions separately.

EU GMP Volume 4, Part I, Chapter 4 (January 2011), §§4.17–4.18 requires an approved written manufacturing formula and processing instructions for each product and batch size. The formula covers product identity, dosage form, strength, batch size, starting materials and amounts, and expected yields. Processing instructions cover location and principal equipment, preparation of critical equipment, line and equipment clearance, stepwise instructions, in-process controls and limits, relevant bulk-storage requirements, and special precautions.

For U.S. drug CGMP, 21 CFR §211.186(a) requires master production and control records for each drug product and batch size, prepared, dated and signed by one person and independently checked, dated and signed by another. The preparation process must be in a written procedure. Section 211.186(b) specifies contents including product identity and strength, components and quantities, theoretical weights and yield criteria, packaging components and approved labeling, and complete manufacturing and control instructions, sampling and testing procedures, specifications, notations and precautions. The current eCFR text was checked in the edition up to date on 15 October 2026.

These requirements do not prescribe one universal MFR layout. The applicable market, dosage form, approved product information and the site’s controlled document system determine how the requirements are presented.

Separate the master instructions from the batch record

The master document sets approved instructions and acceptance criteria. The batch record captures the batch number, materials actually used, personnel and equipment, process observations and results, in-process checks, yields, deviations and approvals required by the applicable system. EU GMP Chapter 4 (January 2011), §4.20 says the Batch Processing Record is based on the relevant parts of the currently approved Manufacturing Formula and Processing Instructions.

Keep changes to the master document controlled. An executed batch record should identify the version used so a reviewer can establish which approved instructions governed that batch.

Organize the document around the process

The following sections are a practical way to organize the required information. They are not a substitute for checking the applicable requirements or approved product documents.

SectionInformation to defineRegulatory reference
Product and batch scopeProduct name and code, dosage form, strength, intended batch size and document identityIndia Schedule M (2023), §17.3.6.2(a)–(b); EU GMP Chapter 4 (2011), §4.17(a)–(b); 21 CFR §211.186(b)(1)
Formula and materialsStarting materials or components, approved names or codes, quantities, units and any material that may be removed or consumed during processingIndia Schedule M (2023), §17.3.6.2(c); EU GMP Chapter 4 (2011), §4.17(c); 21 CFR §211.186(b)(2)–(4)
Weights and yieldsTheoretical weights at relevant stages, expected final and intermediate yields where applicable, and the approved criteria that require investigationIndia Schedule M (2023), §17.3.6.2(d); EU GMP Chapter 4 (2011), §4.17(d); 21 CFR §211.186(b)(6)–(7)
Equipment and processProcessing location, principal equipment, equipment preparation references, clearance checks and sequential instructions with relevant process parametersIndia Schedule M (2023), §17.3.6.2(e)–(g); EU GMP Chapter 4 (2011), §4.18(a)–(d); 21 CFR §211.186(b)(9)
Controls and testingSampling instructions, in-process checks, approved methods, specifications and acceptance limitsIndia Schedule M (2023), §17.3.6.2(h); EU GMP Chapter 4 (2011), §4.18(e); 21 CFR §211.186(b)(9)
Storage, precautions and hold timesRelevant storage and handling details, product- or process-specific precautions, and justified hold times for intermediate or in-process material where requiredIndia Schedule M (2023), §17.3.6.2(i)–(k); EU GMP Chapter 4 (2011), §4.18(f)–(g); 21 CFR §211.186(b)(9)
Packaging informationPackaging components and quantities, line-clearance instructions, packaging operation, controls, and approved label specimens or references; the packaging instructions may be a linked documentIndia Schedule M (2023), §17.3.7; EU GMP Chapter 4 (2011), §4.19; 21 CFR §211.186(b)(8)–(9)

The figures for quantities, parameters, yield limits and test acceptance criteria must come from the approved product and process documents. Do not insert example values as if they were regulatory limits. The finished-product specification addresses shelf-life and storage information under EU GMP Chapter 4 (2011), §4.16; include or reference those details in the formula document where the approved document structure requires them.

A preparation and review sequence

  1. Confirm scope. Identify the product, dosage form, strength, batch size and market. Use the current approved product and process documents as the source for formula and control requirements.
  2. Build the material list. Use controlled material names or codes, quantities, units and any applicable processing notes. Check calculations and the applicable measurement system independently.
  3. Write the process sequence. State the processing location, principal equipment, equipment-preparation references, step order, relevant parameters, sampling points and in-process controls. Use approved values and acceptance limits.
  4. Cover yield, storage and packaging. Include the required theoretical or expected yields, applicable bulk-storage conditions, precautions and packaging information. Link to controlled packaging instructions when the site system maintains them separately.
  5. Review and approve. Check the formula against the approved product documents, confirm every instruction is usable and unambiguous, and complete the applicable independent review and approval. India Schedule M (2023), §17.3.6.1 calls for a formally authorised master formula; EU GMP Chapter 4 (2011), §§4.2–4.5 addresses review, approval, identification, effective dates and keeping documents current; U.S. 21 CFR §211.186(a) sets the specific signature and independent-check requirements for master production and control records.
  6. Issue and reconcile versions. Distribute the effective controlled copy through the site’s document-control system and withdraw obsolete versions under the applicable procedure.

Example in-house criterion (not a pharmacopoeial requirement): A site may organize its controlled MFR with separate sections for product details, formula, equipment, process steps, controls, packaging references, approvals and revision history, provided the applicable regulatory and product requirements are covered.

Batch documentation and retention

Complete a separate batch record for each batch using the approved master instructions and the applicable record procedure. Retain batch-specific GMP records for at least one year after the expiry of the respective product batch. EU GMP Volume 4, Part I, Chapter 4 (January 2011), §4.11 requires batch documentation to be kept for one year after expiry or for at least five years after Qualified Person certification, whichever is longer. Under current 21 CFR §211.180(a), required records are retained for at least one year after the expiry date of the batch, subject to the regulation’s specific provisions.

Frequently asked questions

Is an MFR the same as a BMR or BPR?

No. The MFR or master production and control record contains approved instructions for a product and batch size. A BMR, BPR or Batch Processing Record is the executed record for a particular batch.

Must every MFR have a process flow chart?

The cited EU and U.S. provisions specify required information but do not make a flow chart a universal MFR section. A site may use one as an aid if it is controlled and consistent with the approved stepwise instructions.

Are one set of MFR headings valid for every market?

No. Use the requirements that apply to the product and market. For example, India Schedule M §§17.3.6–17.3.7, EU GMP Chapter 4 §§4.17–4.19 and U.S. 21 CFR §211.186 use different structures and terminology.

References

  1. Ministry of Health and Family Welfare, Government of India. Drugs (First Amendment) Rules, 2023, G.S.R. 922(E), 28 December 2023, Schedule M Part I, §§17.3.6.1–17.3.6.2 and 17.3.7. Official Gazette notification; CDSCO consolidated Drugs Rules, 1945 (September 2024), Schedule M.
  2. European Commission. EudraLex Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Part I, Chapter 4: Documentation (January 2011), §§4.2–4.5, 4.11, 4.16–4.20. Official Chapter 4 PDF; EudraLex Volume 4 index.
  3. United States Electronic Code of Federal Regulations. 21 CFR §211.186, master production and control records (current eCFR text up to date 15 October 2026). Official eCFR.
  4. United States Electronic Code of Federal Regulations. 21 CFR §211.180(a), general record-retention requirements (current eCFR edition, 2026). Official eCFR.

Related articles