!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…
Cleaning validation may be conducted during the PQ phase or the tradi-tional process validation phase in parallel with the manufacturing of the validation batches. The details of the philosophy…
!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 32: Maintenance and Metrology Systems All instruments that control manufacturing facilities, utilities, and equipment must be maintained to ensure they are functioning…
