Part 606 Current Good Manufacturing Practice for Blood and Blood Components

Subpart A - General Provisions

• § 606.3   Definitions

Subpart B - Organization and Personnel

• § 606.20   Personnel 99 × 483

Subpart C - Plant and Facilities

• § 606.40   Facilities 157 × 483

Subpart D - Equipment

• § 606.60   Equipment 313 × 483
• § 606.65   Supplies and reagents 144 × 483

Subpart F - Production and Process Controls

• § 606.100   Standard operating procedures 1,765 × 483
• § 606.110   Plateletpheresis, leukapheresis, and plasmapheresis 4 × 483

Subpart G - Additional Labeling Standards for Blood and Blood Components

• § 606.120   Labeling, general requirements 7 × 483
• § 606.121   Container label 46 × 483
• § 606.122   Circular of information 1 × 483

Subpart H - Laboratory Controls

• § 606.140   Laboratory controls 45 × 483
• § 606.145   Control of bacterial contamination of platelets 4 × 483
• § 606.151   Compatibility testing 63 × 483

Subpart I - Records and Reports

• § 606.160   Records 847 × 483
• § 606.165   Distribution and receipt; procedures and records 9 × 483
• § 606.170   Adverse reaction file 127 × 483
• § 606.171   Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and transfusion services 218 × 483