Master production and control records

Sec. 211.184 Component, drug product container, closure, and labeling records. Sec. 211.186 Master production and control records. 

Master Production Instructions (Master Production and Control Records)... 

Documentation is at the core of all quality systems, and was discussed in Chapter 2. Examples of the types of documentation associated with pharmaceutical production are shown in Figure 11.9. European regulations require that records which permit tracing of the full history for each batch of product should be retained for 1 year after expiry of the product or 5 years, whichever is the longer. US regulations require the retention of records for 1 year after batch expiry or 3 years after the last distribution in cases of some OTC products where no expiry date is assigned. Additionally, the US regulations require the preparation of a Master Production and Control Record ,... 

To assure uniformity from batch to batch, master production and control records for each drug product, including each batch size thereof, shall be prepared, dated, and signed (full signature, handwritten) by one person and independently checked, dated, and signed by a second person. The preparation of master production and control records shall be described in a written procedure and such written procedure shall be followed. 

Use of clear, precise operating instructions, including the documentation of process performance and verification. A company s system includes the issuance of a master production and control record and the batch production and control record (for each batch). These records document the fact that the company continues to manufacture each batch of product with the validated process of record. 

In the United States, drug GMPs were formally introduced in 1963 and included the regulation of computer systems. 21 CFR Part 211.2(b) emphasized computer backups and documentation, including keeping hardcopy of master formulas, specifications, test records, master production and control records, batch production records (batch production and control records), and calculations. 

CFR211.68, Subpart D—Automatic, mechanical, and electronic equipment. (b) Appropriate controls shall be exercised over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. ... 

Master production and control records for each drug product, including each batch size, shall be prepared, dated, and signed (full signature, handwritten) by one person. 

The preparation of master production and control records shall be described in a written procedure. 

This section of the code details what is required in master production and control records. It states that these records shall include the following ... 

CFR Part 210 and Part 211 specifically sections 211.186, Master Production and Control Records, and 211.188, Batch Production and Control Records. 

In this section, include a general description of the manufacturing procedure, including all processing alternatives previously validated as producing acceptable product. The FDA also wants copies of the proposed or actual master production and control record, as well as a copy of a completed production and control record for a typical batch. It is also helpful to provide a schematic diagram for the flow of materials, the production process, and an indication of the equipment to be used. 

Memos, master production and control records, SOPs, deviation reports, validation protocols, manual batch documentation, and many more. 

Master production and control records Components specifications... 

Consider source code (and its supporting documentation) a part of the master production and control records... 

This information that is annotated on executed master production and control records should be evaluated, reviewed and, if necessary, approved, and incorporated utilizing an established change control system. 

In many cases, master production and control records used in the production of clinical supplies start out as batch cards, which are sometimes printed on a heavier stock paper that may be colored (e.g., blue or... 

Reprocessing can be defined as the repeating of a defined step or sequence of steps outlined in a master production and control record, in order to achieve a predetermined endpoint. Written procedures should be established and followed for any reprocessing steps or operations that are incorporated into a developed manufacturing process. The effectiveness of any reprocessing activity should be demonstrated through validation studies and should be fully supported by data. 

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