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Definition of GMP (Good Manufacturing Practices) and cGMP

Definition of GMP (Good Manufacturing Practices) and cGMP

Validation is an integral part of quality assurance; it involves the systematic study of systems, facilities and processes aimed at determining whether they perform their intended functions adequately and consistently as specified. A validated process is one, which has been demonstrated to provide a high degree of assurance that uniform batches will be produced, that meet the required specifications and has therefore been formally approved. Validation in itself does not improve processes but confirms that the processes have been properly developed and are under controls. The processes include raw material and equipment inspections as well as in-process controls. Process controls are mandatory in good manufacturing practice (GMP). The purpose is to monitor the on-line and off-line performance of the manufacturing process, and hence, validate it. Thus validation is an integral part of quality assurance.. Verotech Engineers have been involved in pharmaceutical manufacturing process validation activities with a product lifecycle concept and with existing FDA guidance, including the FDA/International Conference on Harmonisation (ICH) guidances for industry, Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System.We expertise in:•         Equipment validation•         Facilities validation•         HVAC system validation•         Cleaning validation•         Process validation•         ytical method validation•         Computer System Validation•         Packaging ValidationOur Team will provide valuable and informed insight for developing and implementing their client’s comprehensive quality plan.Read more »Successfully validating a process may reduce the dependence upon intensive in process and finished product testing. Our Engineers have been involved in development of various new design concepts for our medical device clientsRead more »Verotech Engineers have been involved in pharmaceutical manufacturing process validation activities with a product lifecycle concept and with existing FDA guidance, including the FDA/International Conference.Read more »The US FDA, European authorities, Health Canada, the Australia Therapeutic Goods Administration and other regulators recognize it as the "de facto" standard for risk management.Read more »We are a professional services firm with a team of Engineers who have wide array of experiences in the fields of Medical Devices and Pharmaceutical Manufacturing.Copyright © 2014 - All Rights Reserved - Verotech Solutions, LLCDesign by RedHot TECHSolutions



Sep 20SLANTING THE TEST TUBE: How can working with conflict facilitate a transformative learning experience?“Maybe we didn’t slant the test tube enough, or we heated it too quickly. In this way we learn what part of the danger lies in the matter and what part in our way of handling it.” – Sigmund Freud [1]Slanting the Test-TubeConflict is one of those loaded words, heavy with meaning, connotations and associations. As human beings we have an ambiguous relationship with it, so adept at creating something we try so hard to avoid. Whether on a large or small scale, much of human conflict appears because of patterns formed in the past that we seem to unconsciously repeat in the present.[2] Based on our deeply embedded pasts, we continue to act out unhealthy modes of relating to one another that can result in blocking learning and growth. Often within organisations, as leaders, facilitators or coaches we’re called upon to resolve conflict.In this Blog entry I discuss how these unconscious projections of emotions and relationship patterns from the past into the present  can be the source of conflicts between individuals and how working empathically with conflict can be a source of transformative learning: creating healthier modes of relating and potentially enhancing individual and team growth.I want to share a personal experience of conflict that helped me in my role as a leadership coach. Andreas (name changed), a 58-year-old, US-based senior business leader was a participant on a seven-day Leadership Developmental event I was facilitating with a colleague. From the first group sessions we facilitated, Andreas continuously questioned the point and relevance of the exercises I introduced to the group. Although I welcome and generally enjoy challenging questions, this enquiry was combined with a general attitude of antagonism. On the first and second day for example, Andreas returned late from all breaks stating to the rest of the group that I had purposely told him different times. On the morning of day three, Andreas asked to address the group and announced how angry he was with me because of the overcast weather, when I had told him the previous day that the forecast was to be good.Andreas’ aggressive behavior was in stark contrast to the behaviors of other members of the group as well as his interactions with my co-facilitator, whom he continuously praised and complimented. At the end of each day my colleague and I acknowledged Andreas’ behavior as striking; I began to wonder whether Andreas was unconsciously presenting patterns from the past in the present. This became a critical question for me as I became more and more concerned that his constant stream of complaint was beginning to block his own learning as well as that of the group’s.   Working with the conflict“Such experiences, though painful, are necessary and hard to avoid. Without them we cannot really know life and what we are dealing with.” – Sigmund Freud [3]Any group interaction can evoke primitive anxieties, particularly in developmental programs that require people to look inward and engage in a process of self-reflection in the presence of others. If we accept Freud’s view of the family group as the prototype of all groups, it’s not surprising that individuals transfer their unconscious patterns of relating from the past into the present, projecting onto people who perform a function once carried out by parents – for example leaders, authorities and teachers.[4]Regarding the different treatments my co-facilitator and I were receiving, we both recognized a clear splitting by Andreas; my co-facilitator and myself were split into two camps – the good facilitator and the bad facilitator. The psychoyst Fairbairn saw splitting as a fundamental defense that emerges due to environmental threats.[5] This led me to consider whether Andreas’ behavior represented unconscious defenses directed against a perceived threat. Greenson advises to take note when behavior is both inappropriate and repetitive.[6] In these instances, the person may well be acting out what Freud termed ‘new additions of old conflicts.’[7]Reflections on my own inner conflict“When we consciously engage the poetic messages the unconscious offers to us, we begin to experience an alignment of our outer lives with the movement of individuation.” – Otto Rank[8]Of course, this powerful and intense activity had an effect on me. I felt under attack and shifted between feelings of frustration and rage and thoughts of bewilderment and inadequacy in dealing with the situation. It felt as if I was in an emotional tug of war. I mentally worked hard not to be triggered into acting out my own unresolved infantile feelings of rage. If triggered, I knew I would reach a complete impasse with my client.[9]At the end of the third day, I decided to address the situation and asked Andreas if we could speak together outside of the group. Andreas questioned why I needed to talk to him and I started to share how I had been feeling. I shared the metaphor of a tug of war in order to express the full range of emotions I had been experiencing during our interactions. Humanistic-based coaching and facilitation confidently promotes self-disclosure as an important means of intervention[10] and research suggests degrees of self-disclosure are effective in the formation of empathic attunement.[11] Nonetheless, in that moment I felt very exposed.“Emotions are contagious…any process of an emotional kind immediately arouses a similar process in others.” – Carl Jung, 1976[12]Emotions are contagious.My self-disclosure seemed to surprise Andreas; he said that he had been completely unaware of the fact that his behavior could have such an effect. He paused and started to share that he too was ‘struggling’. He was finding the intense nature of the leadership program very confronting and felt inadequate in the group. In fact, he admitted that his emotional struggle was so severe that he contemplated leaving the program all together.As we both shared and talked through our felt experiences, Andreas explained how these were not unfamiliar feelings for him when in group situations. The more we explored this, Andreas identified many similar experiences over the years and how this pattern of behaviour significantly hindered his ability to effectively work with and lead teams.  After some time talking, we both sat in silence in what felt like a shared acknowledgment that something important had occurred. Later in my reflections, I identified this as a transformative experience.The reason I use the term transformative is because the experience generated more than a new awareness for Andreas. It also ignited a new and positive agency within him. The immediate impact was a healthier mode of relating between us both. In the following days, Andreas’ behaviour was far less antagonistic. He focused his energy on a positive concern for the exercises and activities at hand as well as proactively contributing to the group’s reflections, insights and learnings.It would have been easier for me to simply seek to resolve the conflict and not work with it as a source of learning. The transformative learning experience requires working beyond the purely cognitive. The transformative learning experience requires working with the emotive experiences that are present as the pathway to helping the individual identify their unconscious patterns of thoughts, feelings and behaviors. The key to this pathway is empathic enquiry combined with a willingness to self-disclose. “Maybe we didn’t slant the test tube enough, or we heated it too quickly. In this way we learn what part of the danger lies in the matter and what part in our way of handling it”.[13] By actively working with our raw emotions, together, we were able to create an environment where Andreas felt safe, able and confident to effectively learn and contribute to the learning of others in the group.[1] Freud, Sigmund (2009). In Wiener, Jan. The Therapeutic Relationship: Transference, Countertransference and the Making of Meaning. Texas A+M University Press, Texas, US[2] Southgate, John (2002). Attachment, Trauma and Multiplicity: Working with Dissociative Identity Disorder. Edited: Sinason, V. Routledge; 2nd Revised ed., London[3] Wiener, Jan. (2009). The Therapeutic Relationship: Transference, Counter-Transference and the Making of Meaning.  Texas A+M University Press, US.[4] Greenson, RR (1967). The Technique and Practice of Psychoysis, Vol 1, London Hogarth Press (reprinted 1974)[5] Holmes, Jeremy. (1996). Attachment, Intimacy, Autonomy. Jason Aronson Inc: London, p. 104[6] Greenson, RR (1967). The Technique and Practice of Psychoysis, Vol 1, London Hogarth Press (reprinted 1974)[7] Wiener, Jan. (2009). The Therapeutic Relationship: Transference, Counter-Transference and the Making of Meaning.  Texas A+M University Press, US.[8] Rank, Otto (1989). Art and Artist: Creative Urge and Personality Development. W. W. Norton & Co: New York.[9] Grinberg, Leon (1970). ‘The Problem of Supervision in Psychoytic Education’ – International Journal of Psycho-ysis 51: 371 – 74[10] Rowan, J & Jacobs, M (2002). The Therapeutic Use of Self. Open University Press, Berkshire, UK.[11] Fonagy, P. Roth, A (2005). What works for whom? A critical review of psychotherapy research. Second ed. The Guildford Press: London.[12] Jung, Carl (1976). ‘The Tavistock Lectures. Collected Works 18’, 1935 in ytical Psychology: Its Theory and Practice. Routledge and Kegan Paul: London.[13] Freud, Sigmund (2009). In Wiener, Jan. The Therapeutic Relationship: Transference, Countertransference and the Making of Meaning. Texas A+M University Press, Texas, US.Enter your email address to follow this blog and receive notifications of new posts by email.Join 1,484 other followers Error: Twitter did not respond. Please wait a few minutes and refresh this page.Did you know you can write your own about section just like this one? It's really easy. Navigate to Appearance → Widgets and create a new Text Widget. Now move it to the Footer 1 sidebar.A wonderful serenity has taken possession of my entire soul, like these sweet mornings of spring which I enjoy with my whole heart. I am alone, and feel the charm of existence in this spot, which was created for the bliss of souls like mine. I am so happy, my dear friend, so absorbed in the exquisite sense of mere tranquil existence, that I neglect my talents. I should be incapable of drawing a single stroke at the present moment; and yet I feel that I never was a greater artist than now. Blog at WordPress.com.





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