Could you please give me any references if it possible. I am really stuck on this question.

As part of their Quality Management Systems, pharmaceutical companies usually produce a Standard Operating Procedure (SOP) for Out of Specification (OOS) Investigations. These SOPs are based on guidelines produced by regulators such as the Medicines and Healthcare Products Regulatory Agency (MHRA) who explain their expectations in these guidelines. Explain the term 'specification' in the pharmaceutical context, what kind of information it contains, where it can be located and why it is important. (maximum 200 words, 30% of marks) Explain the meaning of the term 'Out of Specification' (OOS). What are the reasons for conducting an OOS investigation? Select THREE and explain their benefits to pharmaceutical quality control in more detail. (maximum 200 words, 30% of marks) Why do pharmaceutical companies produce an SOP rather than expect their analysts to use the MHRA guidelines? (maximum 200 words, 20% of marks) Why is an understanding of analytical testing of Medicines relevant to pharmacists? (maximum 200 words, 20% of marks)