a. 2014年3月19日，■■ ■■的安装和运行确认的■■附录被发布给■■，这一操作的实施未报告偏差。（直至）2014年6月12日，发布方案的差异报告（DR）（才）包括■■范围。要求该活动在同一偏差中记录单独的安装和确认操作，而非通过原始方案附加的附录或独立方案。在差异报告发布后，在2014年7月记录了仅针对附录的执行后批准认定。
b. 2015年10月最新版本■■ ■■的■■功能需求和系统设计规格中描述了拟定的■■。然而，如■■中所报告，新的组件于2014年7月通过差异报告（DR）安装。
Routine maintenance of the automated control system is not performed according to a written program designed to assure proper performance. Specifically,
a. There is no preventative maintenance plan including frequency and a description of maintenance activities, available for the ■■ and associated automation controls which are responsible for ensuring the quality manufacture of Prezista 600 mg.
b. As per NIR model maintenance approach ■■ maintenance relies on tracking and ■■ and monitoring of model performance. However, written procedures are not established to track and trend NIR model performance results.
OBSERVATION 2
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Specifically, general user accounts with Maintenance, Supervisor, and Administrative privileges are available for the ■■.
OBSERVATION 3
Records are not kept for the maintenance and cleaning of equipment. Specifically:
1. IQ/OQ protocols executed on site as described in Validation Document Plan ■■ Mar 2015, and approved report ■■ 22 Feb 2016 are not always executed as defined in the plan. For example:
a. ■■ Addendum to the Installation and Operational Qualification to the ■■ ■■ was issued to ■■ the exercise was executed with no reported deviations as of 3/19/14. In 6/12/14, a Discrepancy Report (DR) to the protocol was issued to include ■■ scope. This activity required separate installation and qualification exercises documented in the same deviation and not via an addendum to the original protocol or with a separate protocol. A post-execution approval certificate to only the addendum was documented in 7/2014, after the discrepancy was issued.
b. ■■ Functional Requirement and System Design Specification for the ■■ ■■ described the proposed ■■ in the most recent version dated Oct 2015. However, as reported in ■■ the new part was installed via discrepancy (DR) in 7/2014.
2. ■■ Interim report of the Cleaning Development for the Continuous Manufacturing Line ■■ used for Prezista 600mg at Janssen Supply Chain, Gurabo, was approved in 22-Feb-2016. The report included results obtained for cleaning exercises conducted in order to release the ■■. All results were reported as acceptable, with recommended updates in some of the cleaning times for identified equipment and no additional or reduced testing sites to be executed during the actual cleaning validation.
■■ Validation Protocol to Evaluate the Cleaning Process and Dirty Holding Times for the ■■ used for Prezista 600mg Tablets, was approved on 23-Feb-2016 for execution based on outcome of Cleaning Development exercise documented with Interim report ■■
This protocol ■■ in several pieces of equipment for the ■■ but failed to include documented evidence that would ■■ ■■.
3. Adequate written instructions are not in place for assembling the equipment parts of the formulation component feeders. Job Aid ■■ does not include specific instructions for matching the screws with the correct component feeder.
