The principles of conducting an analytical OOS investigation heretofore described should be invoked throughout an MDD investigation, including proper documentation, collection of data, and interpretation of data by the…
!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 42: Master Batch and Completed Batch Records Clearly written, detailed batch records are critical to ensuring product quality. The master batch record…
!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 39: Shipping and Distribution A finished pharmaceutical’s labeling and/or pharmacopeia monograph provide specific directions for the temperature and humidity conditions of storage…
!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 38: Material Storage, Identification, and Rotation Material Storage Storage locations should meet the general principles outlined for pharmaceutical manufacturing facilities in each…
!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 37: Sampling Processes General Sampling Requirements It is desirable to have written procedures for sampling that include the names of person(s) authorized…
First-Party Audits Internal audits are performed according to a schedule to evaluate the quality system in order to determine if it is effectively implemented and maintained. In addition, they…
!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 36: Receipt of Materials Upon the receipt of any material, all documents associated with the shipment or delivery must be reviewed to…
The PDCA Approach Similarly to ISO 9001 and ISO 13485, ISO 22301 uses what is called the plan–do–check–act (PDCA) cycle, which uses this model to organize the standard: •…
The term CAPA is used to define the program in quality manuals as well as in the standard operating procedures (SOPs) defining the quality system. Whether there is a…
!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 33: Cleaning, Sanitization, and Pest Control Washing Facilities and Cleaning Procedures “Washing and cleaning equipment should be chosen and used in order…
