Description - Figure 2.2.3 Regulations most commonly cited by fiscal year (2006-2010) - Summary report of the Drug Good Manufacturing Practices (GMP) Inspection Program - April 1, 2006 to March 31, 2011

From April 1, 2006 to March 31, 2007 4 % of all observations were noted against the Regulations covering premises, 7 % were noted against the Regulation covering equipment, 7 % were noted against the Regulation covering personnel, 5% were noted against the Regulations covering sanitation, 2 % were noted against the Regulations covering raw material testing, 21 % were noted against the Regulations covering manufacturing control, 35 % were noted against the Regulations covering quality control department, 1 % were noted against the Regulations covering packaging material testing, 5 % were noted against the Regulations covering finished product testing, 7 % were noted against the Regulations covering records, 1% were noted against the Regulations covering samples, 4 % were noted against the Regulations covering stability and 2 % were noted against the Regulation covering sterile products.

From April 1, 2007 to March 31, 2008 5 % of all observations were noted against the Regulations covering premises, 7 % were noted against the Regulation covering equipment, 7 % were noted against the Regulation covering personnel, 5 % were noted against the Regulations covering sanitation, 2 % were noted against the Regulations covering raw material testing, 21 % were noted against the Regulations covering manufacturing control, 32 % were noted against the Regulations covering quality control department, 1 % were noted against the Regulations covering packaging material testing, 5 % were noted against the Regulations covering finished product testing, 8 % were noted against the Regulations covering records, 1 % were noted against the Regulations covering samples, 4 % were noted against the Regulations covering stability and 2 % were noted against the Regulation covering sterile products.

From April 1, 2008 to March 31, 2009 4 % of all observations were noted against the Regulations covering premises, 7 % were noted against the Regulation covering equipment, 7 % were noted against the Regulation covering personnel, 5 % were noted against the Regulations covering sanitation, 2 % were noted against the Regulations covering raw material testing, 18 % were noted against the Regulations covering manufacturing control, 34 % were noted against the Regulations covering quality control department, 1 % were noted against the Regulations covering packaging material testing, 6 % were noted against the Regulations covering finished product testing, 7 % were noted against the Regulations covering records, 1 % were noted against the Regulations covering samples, 4 % were noted against the Regulations covering stability and 2 % were noted against the Regulation covering sterile products.

From April 1, 2009 to March 31, 2010 4 % of all observations were noted against the Regulation covering premises, 7% were noted against the Regulation covering equipment, 6 % were noted against the Regulation covering personnel, 4 % were noted against the Regulations covering sanitation, 3 % were noted against the Regulations covering raw material testing, 19 % were noted against the Regulations covering manufacturing control, 36 % were noted against the Regulations covering quality control department, 1 % were noted against the Regulations covering packaging material testing, 6 % were noted against the Regulations covering finished product testing, 6 % were noted against the Regulations covering records, 1 % were noted against the Regulations covering samples, 5 % were noted against the Regulations covering stability and 3 % were noted against the Regulation covering sterile products.

From April 1, 2010 to March 31, 2011 4 % of all observations were noted against the Regulation covering premises, 7 % were noted against the Regulation covering equipment, 7 % were noted against the Regulation covering personnel, 5 % were noted against the Regulations covering sanitation, 3 % were noted against the Regulations covering raw material testing, 20 % were noted against the Regulations covering manufacturing control, 35 % were noted against the Regulations covering quality control department, 1 % were noted against the Regulations covering packaging material testing, 5 % were noted against the Regulations covering finished product testing, 7 % were noted against the Regulations covering records, 1 % were noted against the Regulations covering samples, 4 % were noted against the Regulations covering stability and 2 % were noted against the Regulation covering sterile products.