Documentation

Importance of SOPs ctd

- Consistency ----- Allows repeating of same procedures and transfer of information - No nationally adopted standards that governs collection and preservation of data - There has not been any establish training guidelines to address this collection and preservation of data

Checklists

- Checklists are used to document completed actions - Any checklists or forms are referenced at the appropriate sections and then attached to the SOP - In some cases, detailed checklists are prepared specifically for a given activity - Checklist are not the SOP, but a part of the SOP

Required components of a date

- Day, Month and Year - The order is usually specified For example : DD/MM/YY or DD/MM/YYYY - Postdating (future date) is a deviation - Backdating (date before an activity) is a deviation - Times should be written according to guidelines

Documentation: Types

- Apex documents - Standard Operating Procedure - Protocol - Procedure - Specification and testing procedures - Plan - Records - Lab notebook - Reports - Labels - Signature - Hand written or electronic - Master formulae - Batch processing and packaging records - Forms

Original guidance dated January 2012

- Bracelet manufacturer should ensure that all bracelets contain at least 5 beads and securely fastened - Bracelet manufacturers using wooden beads should include at least one red bead in the bracelet - Bracelet manufacturer should maintain a list of appropriately qualified persons to whom significant bracelet-making duties have been assigned

Scientific

Knowledge, as of facts or principles; knowledge gained by systematic study

Technical

Peculiar to or characteristic of a particular art, science, profession, trade, etc. technical details

Plan

An outline steps with timing and resources, used to achieve an objective

Document Review Date

Date given after the respective departmental head review or other in consultation with actual user

Document Effective Date

Date of the change or the date of creation

Good Documentation Practice (GDP)

- GDP - Main objective

Documentation: Characteristics

- Identifiable - Legible - Accurate - Prompt - Distinct (clear) - Reliable (consistent) - Complete - Direct - Truthful - Consistency - Traceability - Legal - Current/Updated - Regulated

SOP Preparation

- Procedure needs to be in place for SOP preparation for adequate allocation of procedures and processes that need to be documented - Should be written by skilled professionals with a knowledge of the organization's internal structure - Should be written with sufficient detail and simple enough for comprehension when unsupervised - Experience requirement for performing should be noted in the section on personnel qualifications

Report

A documented evidence of a study

Standard Operating Procedure (SOP)

Is a mandatory requirement for regulated industries

Documentation: SOP definition

- A Standard Operating Procedure (SOP) is a set of written instructions that describe a routine or repetitive activity that is followed under defined conditions. - "Detailed, written instructions to achieve uniformity of the performance of a specific function" International Conference on Harmonisation (ICH) - An authorized written procedure for performing operations not necessarily specific to a given product or material but more general in nature "

Things to consider in your SOP writing

- A sample bracelet provided as a guide - Use score form for grading - Take into consideration every piece of information handed to you - Keep your SOP materials, both graded, ungraded and instructions. - Will be turned in at the end of the semester - Thanks for your anticipated corporation

Importance of SOPs

- Continual improvement of standards of service - Ensures quality and consistency of service - Good practice is achieved - Provides an opportunity to fully utilize the personnel expertise - Role clarification - To prevent failures occur in manufacturing and other processes - Specify essential steps for standardization and quality - To convey advice and guidance staff - For training new members of staff - Provide a contribution to the audit process

Documentation: Intro

- Documentation is a key element in GMP and a part of the quality assurance system - Builds a detailed picture of what a manufacturing function ---has done ---is doing ---yet to do ---where ---when ---and how it is being done

Document Control

- Each organization develops a numbering system to systematically identify and the label the SOP - Document control are described in its Quality - Management Plan On each page is control documentation notation, like a short title and identification (ID) number can serve as a reference designation - Enables referencing when reviewing historical data and is critical for evidentiary records - Page numbering allows the user to quickly check if the SOP is complete - Generally this type of document control notation is located in the upper right-hand corner of each document page following the title page

Documentation: Guidance documents

- FDA Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Section VI. Documentation and Records - ICH Good Manufacturing Practice Guide for API Q7, Section 6 Documentation and Records - 21CFR58 : Good laboratory practice, Subpart J. - ISO 9001- 2008, Clause 4.2 : Documentation requirements - Guide to GMP for Medicinal Products Part 1, Chapter 4 Documentation: PIC/S PE 009-8 (Part I)

Documentation: Purpose

- Identification - Records - Archive/history - Compliance- the act of legalizing - Evidence and confirmation - Verification and validation - Information communication - Accountability and traceability - Render definitions - Evaluation activities ----- Investigation/Inspection, Audit CAPA, Change control - Specifications, methods, procedures, process and policies

A typical GDP document contains

- Logo - Title - Doc. No - Effective date - Revision - Page no - Format - Stamp - Signature - Document numbering Unique document number - Typically issued by a document control department or person (Quality Assurance)

Specifications

- Product/Process - Raw material - Packaging component - Computer program Equipment - For disposables cleaning materials. Documentation control of process deviations

Document review

- Requirement ---Content, context, format and grammar ---Quality attributes of concern -----Correctness, applicability, relevance ---Factors and criteria -----Adherence to standards -----Consistency and traceability -----Readability, comprehensibility, and general understandability -----Technical adequacy and feasibility of approach -----Degree of completeness -----Testability of requirements Use of appropriate requirement, design, or coding techniques

SOP preparation ctd: Example of those who should write SOPs are

- SOPs should be written by an individual performing the routine task or directly responsible for the performance of the task - Those that perform the job or maintenance on tool involved with the operation of which --SOP is written -SOPs are reviewed individuals with appropriate training and experience - Draft SOPs are tested by other individuals that are not the originators prior to approval

Documentations related to product quality

- Specifications - Calibration and test documents - Procedures - Batch records including packaging - Analytical methods - Validation documents

Technical documents

- Specifications - Process descriptions - Operation and assembly instructions - Test protocols - Manufacturer's documentations - Maintenance, cleaning and sanitization procedures and schedules - Calibration documents Machine log book

Procedures

- Standard operating - Quality Control - QA release - Standard process instructions including packaging

GMP documentation-Examples

- Standard operating procedures - Analytical apparatus and calibration - Equipment assembly and validation - Maintenance, cleaning, and sanitization - Environmental monitoring - Pest control and assigning responsibility for cleaning and sanitation - Personnel matters including qualification, training, and hygiene - For the receipt of each delivery of starting material and printed packaging material - For testing materials and products at different stages of manufacture describing the methods and equipment to be used - For the internal labeling, quarantine and storage of starting materials, packaging materials and other materials - Complaints, recalls, returns and sampling

SOP Review and Approval

- The finalized SOPs should be approved as described in the organization's Quality Management Plan - Reviewers -----Generally the immediate supervisor, such as a section or branch chief, and the organization's quality assurance officer reviews and approve each SOP - Signature approval indicates that an SOP has been both reviewed and approved by management - According to elimination Act of 1998 -----use of electronic signatures -----electronic maintenance and ------submission are acceptable

Why do we write procedures?

- Think about what happens if written procedures are not available - Take a look at these sectors of the society - Religion - Judiciary system ---Use reference articles/manual that are written and standardized - Navigation system - Rely on maps and compass

Importance of SOPs ctd.

- To protect the health and safety of employees, and to protect the environment and community - Ensure consistency in operations to maintain quality control of processes and products - To ensure that schedule for processes continue and are strictly followed - Avoid failures that occur in manufacturing and related processes that would harm employees or anyone in the surrounding community - A historical record of the how, why and when and activity was performed in case of modifications or recalls - An explanation of steps in a process that can be reviewed in incident investigations that seek to improve safety practices and operating

Understanding SOP

- What is the objective of SOP (Purpose) - What are applicability and use of SOP (Scope)? - Who will perform tasks (Responsibility) - Who will ensure implementation of procedure (Accountability) - How tasks will be performed (Procedure

Common documentation errors

-Missing signature and dates at the time the activity is performed - The "write over" and the "scribbler" - Non uniform date and signature entry - Data entries that do not correspond to the batch record instructions - Writing a note that activity was performed on one day and signed for on other day - Blanks on batch production records pre-recording of data - Incomplete references - Review not signed - Illegible writing - Too many corrections

Policies

A set of institutional requirements

Log

A specified type of record designed according to intended use ---Issuance and control of equipment logs

Amendment to the version 1 of the original guidance dated January 2012

All bracelets made in Wonderland should be labeled according to this guidance Product name and lot number should be presented on te label Bracelet manufacturer name and date of manufacture should be listed

GDP

Constitutes an essential part of the quality assurance system and is key to operating in compliance with GMP requirements

And after approval

Copies are stamped as "REVIEWED" and next review date.

Procedure

Documented directions for performing certain operations

Record

Documented piece of evidence about the past ---an account of an act or occurrence kept in writing

Main objective

Establish, control, monitor and record all activities which directly or indirectly impact on all aspects of the quality of medicinal products

Documentation is a critical tool for ensuring GMP adherence

GDP is thus a fundamental requirement for every manufacturing and packaging lots of all pharmaceutical products and medical devices to ensure that every product meets the quality requirement according to the regulatory mandate.

Frequency of Revisions and Reviews

SOPs - Need to remain current to be useful - Re-approval is required each time an SOP is updated -----Change date/revision number for that section should be indicated in the Table of Contents and the document control notation - Should be systematically reviewed on a periodic basis, e.g. every 1-2 years - The review date should be specified in each reviewed SOP - A discontinued process should be withdrawn from the current file and archived

Documentation I

Scientific and technical writing; protocol writing, Standard Operating Procedure, essential elements and regulatory requirements

Document Change

Should be recorded at change history at the front page of the document

Technical/ scientific writing

Simply a writing that pertains to a science or any field or subject of interest

GMP regulations require manufacturers to establish and follow scientifically sound and appropriate written controls for

Specifications Plans Procedures - that direct operational and quality system activities to ensure accuracy

SOP Document Tracking and Archival

The organization maintains a master list of all SOPs -This file or database should indicate the SOP number, version number, date of issuance, title, author, status, organizational division, branch, section, and any historical information regarding past versions -The QA Manager (or designee) is generally the individual responsible for maintaining a file listing all current quality-related SOPs used within the organization. If an electronic database is used, automatic "Review SOP" notices can be sent *Note that this list may be used also when audits are being considered or when questions are raised as to practices being followed within the organization